Global Regulatory Affairs Resume Samples

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B Hilpert

Benjamin

Hilpert

3510 Yazmin View

Chicago

+1 (555) 506 1442

3510 Yazmin View

Chicago

Phone

p +1 (555) 506 1442

Experience Experience

Los Angeles, CA

Manager, Global Regulatory Affairs

Los Angeles, CA

Wisozk-Erdman

Los Angeles, CA

Manager, Global Regulatory Affairs

Contributing to the planning, execution, and assessment of product life cycle management activities and strategies
Contributing to, and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities
Contributing to the department-wide work-stream/initiatives, as assigned
Ensure planning and proper organisation of activities (for one of RA specific activities within primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural) in line with the overall project plan and RA milestones
Partners with the Regulatory Policy team to identify, assess and anticipate regulatory policy issues and opportunities that may impact current and future business on a global scale and then to partner with the team, the regions and other related functions to implement a plan to influence the outcome in favor of consumers and J&J
Collaborates with R&D and business colleagues to develop robust yet innovative claims supported with sound science
Provide input to/manage regulatory activities in order to obtain and maintain Marketing Authorisations for commercial products

Los Angeles, CA

Senior Sales Rep, Global Regulatory Affairs

Los Angeles, CA

Bartoletti Group

Los Angeles, CA

Senior Sales Rep, Global Regulatory Affairs

Identify and provide strategic information to support Business Development’s annual plans
Actively network in the industry to establish relationships and to identify potential opportunities
Utilizes CRM to establish reports and dashboards to analyze business development and sales activities and track progress
Cultivate strong relationships with key decision-makers within Accounts and develop deep knowledge of the customer organization
Works with management to identify target customers, markets and services that matches the company’s capabilities
Develop relationships with both Quintiles’ traditional customer base and non-traditional/new customers and markets
Coordinate with our contracts/proposals team to develop proposal

present

New York, NY

Senior Manager, Global Regulatory Affairs

New York, NY

Hoeger-Wuckert

present

New York, NY

Senior Manager, Global Regulatory Affairs

present

Contributing to and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities
Provide input into/manage regulatory activities for development programs in order to obtain Marketing Authorizations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations
Participate to in-depth project/product-related discussions and provide in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of a given project, within GRA meetings
Represent GRA as a member of cross functional brand team review committees, providing regulatory input into the review of advertising, promotion, medical and press materials
Developing and implementing regulatory strategy for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues
Provide input into technical and clinical section/sub-sections for the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
Organizing resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects

Education Education

Bachelor’s Degree in Life

DePaul University

Bachelor’s Degree in Life

Skills Skills

Systems Knowledge – extensive knowledge of Quality Management Systems
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment
Takeda Operations – in-depth understanding of Takeda’s operating philosophy, structure and methods including a thorough knowledge of the foreign‑owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use
Team Working - Ability to work with team members in a friendly, professional manner
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Ability to effectively communicate complex issues both verbally and in writing
Ability to critically analyze complex and/or ambiguous information and the impact on products and process

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15 Global Regulatory Affairs resume templates

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Lead Global Regulatory Affairs Resume Examples & Samples

The role will be working closely together with the IA&P Director to
Develop, integrate and implement within the APAC region, in close collaboration with the LOCs, the local review processes consistent with the International processes
Integrate the Neuroscience BU, as per One Shire, to ensure the review criteria’s are within the global Shire review standards and this role will ensure an aligned review process is set in place throughout all International BU’s and LOC regional responsibilities
Provides expert regulatory review of the internationally developed promotional materials for the NS BU and other products as directed
In liaison with Medical Communications, Medical Affairs and Legal conducts detailed review and evaluation of adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with EMEA approved prescribing information
Ownership of the Pre-CMLR concept meetings to provide expert guidance, pre-empt areas of concern and evaluate draft promotional materials
Assist marketing, in close collaboration with Medical and Legal, with the planning and prioritization of the review of promotional and non promotional materials
Provides LOC CMLR support for the APAC region by close collaboration with the LOC regulatory and Medical contact points, in order to ensure internationally produced pieces are used at the LOC level
Be the key contact point and expert matter for the promotional review process and global review standards across the region
Assist in the development, integration and update of the LOC processes and standards for promotional CMLR review and provide training support

R&D IT Service Manager for Global Regulatory Affairs & QA&C Resume Examples & Samples

Service owner
Service-level manager
IT service-continuity manager
Supplier manager (for the R&D function(s) covered)
IT operations manager
Bachelor's degree in computer science, information systems, business administration or other related field (or equivalent work experience)
ITIL certification (preferably for service management, which implies ITIL Service Management Practitioner certification) and project management training certification (preferred)
Typically at least five to ten years of IT work experience and three to five years in an R&D organization related to the service function in an environment similar in size and complexity to the organization (required)
Demonstrable and recent experience in service operations/managing an external service provider
Strong knowledge of IT Computer Systems Validation processes is required

Associate Director Global Regulatory Affairs Resume Examples & Samples

An advanced degree (MS, PhD, MD or Pharm D) is preferred
A Bachelor’s Degree with a minimum of 8 years of relevant experience (pharmaceutical, regulatory, etc) OR Masters/PharmD with a minimum of 6 years relevant experience OR PhD with a minimum of 4 years relevant experience is required
Extensive experience in US Regulatory laws, regulations and guidance is required
Experience in US Regulatory Phase 3 development (BLA/NDA), preferred
Ability to work successfully within a team environment and as an individual contributor is required
Scientific knowledge of RMAT space, and an understanding of RMAT development and regulatory submission and approval process, preferred
Working knowledge of worldwide health authority laws, regulations, guidance and global regulatory routes available for new study drugs, preferred
Experience working with regulatory policy focused efforts, preferred
The position is based in Spring House with flexibility to work from other J&J facilities up to 2-3 days/week based on business needs, and may require approximately 10-15% domestic travel

Global Regulatory Affairs Administrative Assistants Resume Examples & Samples

University student of Chemistry careers (MANDATORY)
Computers skills and Microsoft office knowledge, specially excel
Fluent in English (MANDATORY)

Associate Director, Global Regulatory Affairs Resume Examples & Samples

Ensures regulatory requirements and opportunities for regulatory innovation and external influencing are incorporated into marketing and R&D development plans and through the transition of the products into the regions for regulatory approval, launch and post-launch lifecycle
The incumbent will partner with global franchise business, global regulatory colleagues and R&D partners and is a member of the franchise R&D project teams. He/She provides leadership in the development of regulatory strategy for global projects to ensure products are developed in a way that will facilitate prompt regulatory approvals with competitive positioning in the intended markets
Develops or ensures the development of a Global Core Dossier to facilitate document transfer to the regions to undertake the necessary regulatory pre-market analysis and authorizations
Partners with the Regulatory Policy team to identify, assess and anticipate regulatory policy issues and opportunities that may impact current and future business on a global scale and then to partner with the team, the regions and other related functions to implement a plan to influence the outcome in favor of consumers and J&J
Collaborates with R&D and business colleagues to develop robust yet innovative claims supported with sound science
A minimum of a Bachelor’s Degree in Life Science or related discipline is required. An advanced degree is preferred
A minimum of 10 years experience working in the device, pharmaceutical or OTC environment is required. Knowledge of multiple regulatory classifications across multiple countries is preferred
Strong business acumen and external partnership approach is required
Leadership and organizational skills, interpersonal skills, and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercials are all required
This role will require up to 10 % travel including both domestic and international travel

Manager, Global Regulatory Affairs Resume Examples & Samples

Organizing resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects
Developing and implementing regulatory strategy for the assigned projects. Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues
Contributing to the planning, execution, and assessment of product life cycle management activities and strategies
Contributing to, and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities
Experience. BS/BA in Life Science or relevant field
Four (4) years of broad pharmaceutical industry experience, including 2 years’ experience of new drug regulated product strategy and submissions
Ability to assume accountability for a project goal/objective
Ability to distill and succinctly communicate strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial)

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

Contributing to and implementing strategy for interactions and negotiations with health authorities. May autonomously handle routine communications with regulatory authorities
Contributing to the department-wide work-stream/initiatives, as assigned
BS/BA in Life Science or relevant field
8 years of broad pharmaceutical industry experience, including 4 year experience of new drug regulated product strategy and submissions
Experience of the Drug Development process and working with international project teams
Working knowledge of relevant drug laws, regulations and guidance's/guidelines
Desirable to have previous experience in CNS therapeutic area
Experience in leading team discussion to resolve and reach agreement on project issues

Director Global Regulatory Affairs & Clinical Safety Resume Examples & Samples

The candidate should have experience managing professional scientists
The ideal candidate will have strong experience in Regulatory CMC, as well as development, manufacturing or quality assurance experience
He/she must be detail oriented with strong leadership/people management skills and excellent interpersonal and communication skills
The candidate must have a proven record of working with and influencing multi-disciplinary teams and external experts and must have demonstrated leadership, communication, problem solving and decision making skills
The candidate must be proficient in English; additional language skills are a plus
The candidate may be required to travel on a periodic basis
The candidate is expected to develop and possess an expert knowledge of Industry Association Whitepapers, HA regulations & guidance documents
He/she is expected to utilize the expert knowledge and reputation to influence the content of new Industry Association Whitepapers, HA guidance & regulations

Associate Director, Global Regulatory Affairs Resume Examples & Samples

Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team and provides regulatory input for the project(s) globally. In this capacity, the GRL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL will work closely with members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis
The GRTL will work transversally to ensure a properly functional Global
Provide regulatory due diligence assessments of new business opportunities as required
Depending on the program assignment, GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed
Strategic
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-GZ

Head, Global Regulatory Affairs Compliance Resume Examples & Samples

Development and leadership of the regulatory activities at a global level in collaboration with Head of GRA and GRA OOC, QMS, and Labeling compliance team members
Ensuring policies and standards are understood and followed
Ensuring alignment and proper communication and training around systems and guidance
Identifying potential areas of compliance vulnerability and risk. Developing mitigation plans to proactively reduce risk
Be the channel of communication for compliance related issues
Providing training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts
Lead and manage day-to-day compliance support for GRA and/other business groups that may be appropriate, including audits and inspections and support for global regulatory compliance activities
Ensures that Takeda GRA organization is compliant with regard to any outsourced or vendor/partner work performed on behalf of Takeda GRA
Bachelor’s degree (or equivalent) required. Masters preferred
Substantial experience in Pharmaceutical industry, with good exposure to Regulatory Affairs, research and development, quality assurance/compliance, and labelling requirements
Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively the interactions necessary for achieving business goals and objectives
Vendor management experience. Knowledge and experience in successfully leveraging externalization efforts across complex reporting environments
Ability to identify proactively and anticipate risk of non-compliance in a complex environment
Solid QMS experience. Experience in the development, implementation and maintenance of a QMS as well as GxP, 21 CFR Part 11 computerized system
Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing
Excellent analytical, technical and problem solving skills
Personnel management experience
Project management and change management experience recommended
Systems Knowledge – extensive knowledge of Quality Management Systems and global labelling requirements
Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes
Takeda Operations – in-depth understanding of Takeda’s operating philosophy, structure and methods including a thorough knowledge of the foreign‑owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Communication – ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders
Team Working - Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high pressure environment. Experience interacting with external resources and partners
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize
Project Management abilities

Assoc Director, Global Regulatory Affairs Resume Examples & Samples

Manage projects related to CMC submission timelines and deliverables or projects that impact business processes, organizational operations, and/or resource management capabilities to support overall Global Regulatory Affairs CMC operations
Lead the planning and creation of a detailed project plan for projects with input from identified stakeholders
Initiate and lead discussions to facilitate the refinement of the project scope, goals, and deliverables
Manage a full scale project plan with tasks through collaboration with functional representatives
Identify appropriate resources for each task through collaboration with functional representatives
Facilitate project discussions to ensure progress and identify appropriate team actions and risks
Ensure project tasks are completed and necessary action plans are executed on to ensure progress and manage risks
Meets project objectives through management of scheduling conflicts, resource constraints, and financial forecasting
Create and manage project artifacts during all phases of the project (e.g. charter, project plan, close out report, etc)
Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
Track project deliverables through appropriate tools and framework; report to all project stakeholders
Expert in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and experience with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting)
Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines
Capability to work effectively in matrix organizational structures
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing

Director, Global Regulatory Affairs Resume Examples & Samples

Bachelor’s degree (or equivalent) required. Masters preferred
Have 5+ years experience managing a vendor management office for a pharmaceutical/medical company; including contract negotiation, vendor performance management, preparing and evaluating RFPs, relationship management, and a strong understanding of project management methodologies
Should have 5+ years of experience managing technology vendors including contractual performance
Substantial experience in Pharmaceutical industry, with good exposure to Regulatory Affairs, research and development, quality assurance/compliance, and labelling requirements
Familiarity with inspections and audit procedures
Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and proactively the interactions necessary for achieving business goals and objectives
Ability to identify proactively and anticipate risk of non-compliance in a complex environment
Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing
Excellent analytical, technical and problem solving skills
Personnel management experience
Systems Knowledge – extensive knowledge of vendor management, the regulatory function, and general pharmaceutical environment
Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Communication – ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders
Team Working - Ability to work with team members in a friendly, professional manner. Motivate and empower others. Manage teams to work productively in a high pressure environment. Experience interacting with external resources and partners
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize
Project Management abilities

Associate Director Global Regulatory Affairs CMC Resume Examples & Samples

At least a Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with 10+ years of pharmaceutical industry experience
OR a Master’s degree with 8+ years of pharmaceutical industry experience
OR a PhD degree with 6+ years of pharmaceutical industry experience
At least 5 years of experience in Regulatory Affairs-CMC is preferred
Knowledge of chemistry, pharmaceutical technology and/or analytical methodologies
Strong knowledge of EU and FDA regulations is required. Knowledge of regulations of other countries is a plus
Direct and significant regulatory experience in CMC documentation preparation for MAAs, NDAs, … is highly preferred
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously
IT-knowledge with different systems is proficient
Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader

Executive Director, Global Regulatory Affairs Resume Examples & Samples

MS is required (minimum requirement); doctoral degree preferred
Generally has at least 12 years of pharmaceutical industry experience with at least 10 years of executive management level experience within regulatory affairs
Highly developed industry and regulatory acumen with the ability to formulate strategies and operational plans that address the interests of the Company
Demonstrated ability to lead a complex, global regulatory organization
Ability to ensure that talent pipelines are proactively managed to ensure departmental leadership needs for the future
Highly developed understanding of global regulatory dynamics
Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through continual communication of group mission and team based outcomes
Ability to provide motivational leadership to help the global regulatory organization understand the company’s strategy and future
Ability to shape and implement and sustain change efforts and instill a culture of accountability and nimbleness

Global Regulatory Affairs Resume Examples & Samples

Processing of non-strategic FDA required submissions not in eCTD format (including User Fees, Self-Identification, Establishment registrations, etc.). Creation and distribution of periodic user fee payment reporting
Maintenance, tracking and reporting of annual report submission activity and initiation of late routine report forms Management of GRO tracking tools and processes (e.g., maintaining procedures list, Routine Report schedule, Regulatory Professional Learning hosting and tracking, etc)
Maintain GRO SharePoint and Regulatory Connect site. Process data/records into SharePoint systems, access requests, maintain content currency)
Compile and submit routine requests on behalf of GRA (e.g., CPPs, PLAIRs)
Bachelor’s Degree, or equivalent combination of education and experience
Degree in science or engineering preferred
3-4 years of experience in an FDA-regulated industry (pharma, device) in a technical role (quality, regulatory, clinical)
Previous experience in pharmaceutical regulatory affairs. Specific experience with FDA submissions, CCPs, GDUFA and PDUFA fees preferred
Mastery of Microsoft Office (including Word, Excel and Project), Adobe Acrobat. Working knowledge of SharePoint
Knowledge of cGMPs and the laws and regulations for the pharmaceutical industry
Understanding of FDA User Fees, basic FDA submissions and FDA certification processes

Global Regulatory Affairs Post Approval Maintenance Associate Health Resume Examples & Samples

Responsible for delivery of dossier/technical file to agreed time frames and collaborate across partner functions to ensure timely delivery of all information required, to enable robust and consistent project updates
Ensure high quality and accuracy of the dossiers vs the agreed requirements and highlighting of any potential issues, working with the authoring functions and LRA
Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market
Educated to honours degree level in a scientific field or equivalent experience
Excellent Project Management Skills
Regulatory Experience and knowledge in NPD and dossier/technical file creation and global registrations

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

This position is responsible for ensuring the CMC regulatory strategy for biologic products remains aligned with defined regulatory, development, and commercial strategic goals
Serves as the GRA CMC lead on Global Regulatory, Global Chemistry and other relevant project teams
Independently provides CMC regulatory advice and strategic guidance to the global development team on development issues
Plans, manages, and executes all CMC regulatory activities for compound(s) in various phases of development, including global registrations and post-approval life cycle management activities for marketed products
Ensures that registration dossiers are developed and approved with appropriate input from internal and external functional areas such that the strategic goals are met and the CMC sections of regulatory submissions satisfy appropriate regulatory requirements
Serves as the GRA-CMC lead in Health Authority meetings and leads CMC preparation related activities for meetings with Health Authorities
Interacts directly and indirectly with FDA and international Health Authorities as necessary
Interacts directly and indirectly with regional and international colleagues within regulatory affairs, external functional areas, and Alliance Partners
Ensures line management and key stakeholders are apprised of ongoing developments, exercising sound judgment, appropriate levels of teamwork and independent responsibility, and maintaining professional working relationships
Serves as a CMC expert within Takeda and represents the company in industry groups/forums as appropriate, actively contributing to knowledge sharing through providing individual and team guidance as well as giving presentations on relevant regulatory topics
BS/BA Degree required, preferably in Chemistry, Biochemistry, Molecular Biology, Biology or related field. Advanced degree helpful
5-7 years of pharmaceutical product development experience and 3-5 years of biologics Regulatory CMC experience
Experience with combination product development desired
Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings
Understanding of scientific principles and regulatory/quality systems and requirements relevant to global biologic drug development and post-market support
Proven ability in providing strategic regulatory guidance to biologic development and post-market support teams, merging scientific principles and global regulatory requirements for new product development, global registration and post-market product maintenance
Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance
Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to Manager
Active participation in industry groups/forums a plus

Senior Associate, Global Regulatory Affairs Resume Examples & Samples

A minimum of 6 years overall professional experience is required
Experience working in a business management, project management and/or science related role, is preferred
Experience working in the pharmaceutical, medical device, and/or consumer industries is preferred
General knowledge of the regulatory environment, guidelines and practices globally is required
Knowledge of Regulatory Affairs - CMC is preferred
Experience as people leader, mentor, and /or project manager is preferred
Excellent organizational skills and the ability to manage multiple tasks / projects / priorities and complex software systems simultaneously are required
The ability to work effectively in a matrix environment, and communicate with cross-functional teams and local affiliates throughout the world is required
Thorough knowledge of MS Office suite of products and data management tools is required
This role will be located in Raritan, NJ or Titusville, NJ and may require up to 5% domestic and international travel

Global Regulatory Affairs Program Manager Resume Examples & Samples

Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals/registrations/licenses of Diagnostic products in global markets
With Regulatory Management, develop regulatory strategies related to Diagnostic product development, including Companion Diagnostics
Provide regulatory assessments and plans for international product registrations and approvals
Interact and collaborate with regulatory bodies and pharmaceutical partners
Ensure the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts
Work across the Agilent organization to ensure alignment of regulatory processes, standards and compliance
Provide expertise and advice in obtaining product registrations and approvals in the Europe/EU Region
Stay abreast of global IVD regulations and guidance
The candidate must have excellent oral and written communication skills

Manager, Global Regulatory Affairs Resume Examples & Samples

A Bachelor’s degree with a minimum of 8 years of relevant experience is required (6+ years with an advanced degree). An advanced degree is preferred
Excellent oral and written communication skills are required. Excellent interpersonal skills are required. Experience operating in cross-functional teams is required
Global experience is an asset. Experience developing regulatory strategies is preferred. Experience developing regulatory dossiers is an asset
This role will require up to 10% travel including both domestic and international

Director, Global Regulatory Affairs Strategy Resume Examples & Samples

Oversee the development and implementation of new product regulatory strategy, considering the different legal status of the products, such as food supplements, food, cosmetics, medical devices or medicinal products, in the respective regions as applicable
Lead and manage the team, ensuring development of team members by defining and implementing individual development plans and assessing performance
Estimate and allocate team resources to accomplish objectives
Translate the strategy into clear and measureable objectives for the regulatory team and ensure that the appropriate business processes are defined and followed
Proactively identify regulatory issues/risks and design/execute mitigation plans
Support proper and timely registration/notification of products in all countries
Direct and supervise all team interactions with competent authorities or government bodies responsible for pharmaceuticals, food, cosmetics, or medical devices, as applicable
Monitor and shape evolving legislation in all categories affecting the portfolio together with Regulatory intelligence
Ensure team processes and activities are aligned with Infrastructure group
Identify gaps in regulatory processes in the Therapeutic Area and develop remediation for those, by defining new processes, documenting them, and training involved personnel
Participate as regulatory expert in mergers and acquisitions performing the regulatory due diligence on dossiers, resulting in recommendations on the planned acquisition from a regulatory point of view, as well as resources needed to deal with the acquired products
Participate in meetings with KOLs or external experts
Provide regulatory guidance for assigned projects as applicable
Deputizing as needed for Head of GRA in governance/decision bodies such, Global Quality Council, PQSC, etc

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

Working with global colleagues (if applicable), leads the regulatory working team and represents team at GCDT ensures global regulatory strategy written and executed according to plan – or oversees if delegated to staff
Accountable for all submissions and approvals of project(s) of responsibility or oversees direct reports responsible
Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieveing major submissions
Accountable for ensuring all other regulatory submissions within outside of region are submitted on schedule by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy
Oversee multiple projects and manager individual projects
For the project(s) of responsibility, collaborates with global colleagues and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside of region to ensure regional execution of the strategy as agreed within the global regulatory strategy
Develop/author and execute global regulatory strategies for more complex strategies. May oversee execution
Executes day-to-day activities for projects or delegates to staff with oversight
Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility
Direct point of contact with health authorities, leads and manages regulatory authority interactions/meetings
Lead and manage Agency meetings
Lead regulatory reviewer in due diligence for licensing opportunities
Identifies and proposes solutions to the management of for any resource gaps for areas of project responsibility
Provides oversight to ensure regulatory compliance of marketed products
Present to senior management as requested
Usually includes supervision of one or more direct reports
BSc Degree preferred. BA accepted
A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience
Solid working knowledge of drug development process and regulatory requirements, knowledge of FDA, EU, Canada, ROW, and post-marketing a plus
Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
Generally strong leader who is effective manager and is able to bring working teams together for common objectives, people management experience preferred

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

Represent GRA as a member of cross functional brand team review committees, providing regulatory input into the review of advertising, promotion, medical and press materials
Act as a single point of regulatory contact for the team on US regulatory issues
Work with and participate on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for programs and products
Ensure development of robust regulatory strategies for marketed products and be accountable for development and maintaining regulatory strategy documents
Primary liaison with FDA for products in remit
Ensure appropriate communication of Health Authority documents and appropriate updating and compliance of applications (PSURs, DSURs etc.)
Consults with senior management to develop and communicate regulatory strategies and opinions for products and programs
Participate in the development, monitoring and updating of standards and processes related to drug and biologics regulations
Provide global support for regulatory issues or related questions that may arise related to products in the portfolio
Supervise, and/or coach mentor, junior staff supporting regulatory team
2-5 years post-marketing regulatory experience
Prior experience maintaining INDs, CTAs, BLA, NDAs, MAAs and working in a global environment
Prior experience reviewing prescription drug advertising and promotion materials
A BS in a scientific discipline. An advanced degree preferred. #LI-SA

Associate Director Global Regulatory Affairs Resume Examples & Samples

Ensure the execution of regional regulatory plans in line with the product’s global registration strategy in collaboration with the global regulatory leader
Depending on the candidate’s skill-set, develop high quality globally aligned regulatory strategies to achieve optimal development objectives
Manage and communicate timeline changes related to health authority submissions
Conduct regulatory review of promotional material in accordance with company policies and guidelines as the regulatory representative on the Promotional Material Review Committee
Planning, coordinating, authoring, and preparing regulatory submissions within the region, including both pre-approval and post-marketing submissions
Review of nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
Lead and coordinate local project team members in developing strategy for applicable documents/activities
Liaison between regional health authority and company for assigned projects and as deemed appropriate by the Global Regulatory Leader
Depending on the skill-set, lead the respective regional health authority meeting and interface directly with the local health authority
Assist with the development the global regulatory functional plan through the research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
Accountable in conjunction with the GRL for maintaining the company core data sheet along with the regional product information documents through the product life cycle
Provide updates at the Global Regulatory Team (GRT) meetings and project teams as needed
6-10 years of biopharmaceutical industry experience with 5 years emphasis in regulatory affairs ideally spanning Phases I-IV
Prior history with post-marketing/brand optimization strategies and commercial awareness
Solid understanding of FDA and ICH regulations/guidance pertaining to pharmaceutical/biologics development
Experience interacting with the FDA
Experience developing regional and global regulatory strategies in coordination with clinical plans and marketing objectives
Proven ability to analyze and interpret efficacy and safety data
Major involvement in NDA/MAA/CTD submissions and approval
Leadership role in health authority negotiations

Manager, Global Regulatory Affairs Facilities Resume Examples & Samples

Bachelors degree (Science) and at least 5 years of relevant experience
Knowledge and experience in US regulations pertinent to CMC Establishments/GMP
Knowledge and experience in CMC Establishments/GMP/ Equipment Validations
Experience in QA/CMC
Experience in interacting with external organizations and Health Authorities pertaining to regulation of CMC establishments and QA
Experience in providing strategic advice on CMC Establishments/ Equipment Validations in cross-functional teams
Experience in securing approvals and life cycle maintenance for CMC Establishment Regulatory function
Detailed knowledge of CMC, QA preferred, especially in Vaccines/Biologicals
Demonstrated written and oral communication skills
Ability to strategize, problem solve and influence

Global Regulatory Affairs Resume Examples & Samples

20%
Master’s or doctorate degree or equivalent in pharmacy, chemistry, biology or related science field preferred
Generally has at least 15+ years of related pharmaceutical experience, including management positions within the pharmaceutical industry; or equivalent combination of education and experience
Global experience required

Director Information Systems Global Regulatory Affairs & Safety IS Services Resume Examples & Samples

Keep abreast of emerging technologies in the areas of business process automation, social media listening, natural language processing, digital health, data mining, analytics, and visualization to apply innovative approach in implementing solutions to enhance these business capabilities and position Amgen ahead of its peers
Shape Amgen's future IS roadmaps - track and evaluate business (GRAAS) and technology trends, connect and foster external networking opportunities to deliver valuable insights from other similar professionals in our industry
Demonstrated ability to combine strategic business and technical direction, and translate concepts into actionable implementation plans
Accountable for "Run" and "Build" project portfolio execution and ensure all systems are GxP compliant, inspection ready, and meet Amgen's IS security standards
Lead a team of IS professionals, invest in staff career development, and provide an environment of learning, risk taking, and collaboration
Manage the execution of a varied portfolio of IS projects with appropriate portfolio planning, financial, resource, vendor and risk management, leveraging agile approaches for flexible and nimble execution
Oversee external vendors that provide day-to-day support and maintenance of several systems; working closely with the vendors to drive operational excellence
Excellent executive level influencing skills, with demonstrated ability to work collaboratively and effectively with key business partners, IT leadership teams, and external services providers
Demonstrated ability for strategic IT planning and roadmap development
Working knowledge of LEAN/AGILE software development methodologies
Experience in enhancing organizational talent through staff development
Strong influence and leadership skills, ability to operate across boundaries (internally/externally)
Organizational change management and project management skills
Experience in the pharmaceutical and/or healthcare industry
Experience in implementing and supporting systems for Pharmacovigilance, Regulatory Affairs, or Labeling systems

R&d-global Regulatory Affairs RA Specialist Resume Examples & Samples

3 years + in the pharmaceutical industry or research organization, with demonstrated organizational skills
Good writing skills, able to negotiate with individuals at same time as understanding departmental constraints/pressure (act with empathy, build network and goodwill) within a highly complex organization (matrix structure, multi-disciplinary and multi-cultural teams)
Good interpersonal, communication (including presentation) and influencing skills
Fluent in written and oral English
Good organizational skills, effective time management, ability to manage multiple tasks
Good communication skills, from simple communication to negotiation skills , with internal GSK stakeholders (i.e. Management of Production, QC, R&D), but also when required with external non-GSK stakeholders (i.e. regulatory Authorities)
Provide timely quality support to Projects, Regions and Cross-products Function through writing of worldwide technical regulatory documentations
Writing and timely delivery of high quality harmonized/standardized ”Right First Time” technical regulatory documents, as agreed with the business partners (Projects, Regions, & Cross-product function)
Liaising with data generating units within the organization (e.g. GIO, R&D) to ensure adequate receipt of documents in order to write CMC documents of high quality
When applicable, review technical documents prepared by Portfolio/Projects: content and QC check
Internal and external interactions
As applicable, provide adequate input into strategic and scientific expertise to development and life-cycle projects, as appropriate
In partnership with Portfolio/Projects and Cross-product Function, provide adequate input in strategic and scientific expertise to GSK Vaccine Advisory Bodies, as appropriate
In partnership with Portfolio/Projects, Regional RA teams and Cross-product Function, participate in adequate and efficient interactions with regulatory authorities to optimize scientific RA strategy and content of regulatory documents and files
Interact appropriately with other RA groups (Facility, Cross-product, Projects, Regions)
Knowledge management
Share technical (CMC) regulatory and knowledge based expertise within the CMC teams
Participate in transversal product-related matters, as appropriate
Ensure technical file content are prepared in line with high regulatory and scientific standards, and/or templates

Senior Sales Rep, Global Regulatory Affairs Resume Examples & Samples

Actively prospect and leverage potential new business opportunities (including early / proactive engagement opportunities) within specified potential new and/or existing Customers/Accounts
Seek out opportunity by uncovering client business pains and mapping those business pains to Global Regulatory Affairs’ service solutions
Works with management to identify target customers, markets and services that matches the company’s capabilities
Participate in the analysis and definition of efficient, cost effective and creative solutions which help the customer become more competitive
Cultivate strong relationships with key decision-makers within Accounts and develop deep knowledge of the customer organization
Actively network in the industry to establish relationships and to identify potential opportunities
Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards
Monitor status of leads and opportunities to ensure a pipeline of opportunities is maintained
Monitor actions and results against plans
Work with Sales Reps, Account teams and business unit managers to identify sales team and prepares and leads the sales pitches and Bid Defense. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale
Coordinate with our contracts/proposals team to develop proposal
Utilizes CRM to establish reports and dashboards to analyze business development and sales activities and track progress
Communicate all account activity to Global Sales Leader GRA individuals through the CRM system
Prioritize current opportunities to align with organization's stated goals and objectives
Provide support standardized and creative proposals in response to customers’ expressed needs. Follow up on proposals to customers. Maintain customer, proposal and contract database/tracking systems
Develop relationships with both Quintiles’ traditional customer base and non-traditional/new customers and markets
Handle customer inquiries and requests for information from both internal and external customers in a timely manner
Support sales and marketing services
Identify and provide strategic information to support Business Development’s annual plans
Proven and demonstrable track record of prospecting excellence
Proven ability to reach and meaningfully interact with mid-level and high-level contacts in Regulatory Affairs
Ideally, a good understanding of the Regulatory Affairs space and titles
Excellent verbal skills
Attention to detail and ability to work simultaneously on multiple priorities
Excellent skills using Microsoft Office Suite
Ability to maintain demanding timelines
Bachelor's degree, or equivalent experience, 2 years related Pharmaceutical Industry experience, a familiarity with Global Regulatory Affairs roles and responsibilities
5 years Inside Sales
An ability to pick up, understand and articulate complex concepts quickly
A desire to grow into outside sales role
An equivalent combination of education, training and experience

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

MSc, General Science or Life Sciences with 5+ years significant experience in regulatory affairs, or appropriate relevant experience
Broad knowledge is required and covers scientific as well as regulatory expertise
Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred
Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
Ability to resolve problems through resourceful use of information and contacts
Quality mindset
Able to input into the Company’s regulatory positioning, and write /critically review key documents targeting internal or external key audiences
Ph.D. or M.D., Pharmacy, Chemistry, Biology or Medicine with 7+ years significant experience in regulatory affairs, or appropriate relevant experience
Experience in the vaccine industry highly desirable
Provide input into/manage regulatory activities for development programs in order to obtain Marketing Authorizations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorizations
Provide input into the content of relevant sections (technical/non-clinical (NC), clinical/labeling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Pediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements
Provide input into briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.)
Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies
Participate to in-depth project/product-related discussions and provide in-depth strategic, scientific and RA input, for clinical/labelling or technical/NC or procedural aspects of a given project, within GRA meetings
Provide in-depth input on technical/NC or clinical/labelling or sections/sub-sections of the Global Regulatory Plan (GRP)
Provide input into technical and clinical section/sub-sections for the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
For cross-product sections or stand-alone documents, work with the function to ensure content is aligned with targeted overall profile of the product

Global Regulatory Affairs Quality Operations Manager Resume Examples & Samples

A degree (BSc/MSc or equivalent in life science, pharmacy, law or business economics preferred)
A minimum of 6+ years’ experience in managing Quality Management Systems including procedural document development, Training requirements and conducting audits
Demonstrated sound judgment and flexible approach to managing situations
Customer service focus

Summer Intern Global Regulatory Affairs Development Oncology Resume Examples & Samples

Perform research into regulatory filings, regulations and other pertinent issues as requested
Compile and present to regulatory oncology organization on specific regulatory intelligence projects
Assist with filing information into regulatory databases and documentation systems
A current student in an undergraduate or graduate program
Basic science knowledge. Possesses strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Demonstrates an interest in developing skills in the area of regulatory strategy and regulatory science
Ability to work in a matrix environment and manage multiple priorities independently. Works well with others

Senior Associate Global Regulatory Affairs Development CNS Resume Examples & Samples

Works with cross-functional teams to communicate submission requirements, obtain and review technical information for the preparation of IND and NDA Annual Report, safety and information amendments for submission to FDA for proper positioning, context and completeness
Ensures all data for submission are complete and in compliance with company guidelines and FDA regulatory requirements
Responsible for achieving routine submissions (e.g. IND amendments)
Responsible for researching and assisting in the preparation of general responses (formulating and/or editing) for clinical and non-clinical data from FDA
Provides regulatory review of clinical trial documents (protocols, reports, etc,) as identified by applicable SOPs for submission to FDA
Attends study team meetings and provides regulatory guidance on regulatory administrative and logistical issues
Assists with agency meetings
Executes global regulatory strategies
Supports individual projects
Works well in a matrix environment and can manage multiple priorities. Works well with others

Manager, Global Regulatory Affairs Team Resume Examples & Samples

Managing all elements of compliance-based examinations and similarly scoped internal audit or independent professional engagements
Acquiring and delivering all pre-examination or pre-audit information requests on a prompt and comprehensive basis through necessary engagement with bank and affiliate staff
Planning and overseeing all consumer compliance exam and audit engagement activities, including advance planning to arrange for temporary workspace needs, schedule onsite meetings (including opening meetings, overview sessions, regular leadership updates, and exit meetings), and manage assignment and delivery of onsite information requests
Effectively managing the orderly retention of records tied to all exam or audit requests
Tracking and ensuring timely completion of actionable items arising from bank examinations (e.g., MRA’s, Violations of Law, Recommended Actions, etc.) and IAG actionable findings
Effectively leading various initiatives and projects as a result of examinations, audits and other external professional engagements as required
Actively representing U.S. Banking Compliance on assignments to various internal committees
Performing special projects, compiling data and preparing reports for Senior Management and other staff, as needed
Direct experience with banking (including credit card operations), compliance, and/or regulatory examinations is preferred
Knowledge of credit and charge card related regulations, deposit related regulations, and other generally applicable consumer compliance regulations is preferred
Ability to engage with internal and external business partners, including senior leaders, to coordinate interactions with and responses to regulatory examiners
Strong attention to detail, including the ability to handle multiple and concurrent examination and audit engagements on a time sensitive and deadline-driven basis
Strategic and tactical leadership skills, in addition to sound judgment and decision making
Professional communication and presentation skills
Possess interpersonal skills and the ability to work without direct authority
CRCM coursework and/or certification is a plus
Bachelor's degree or advanced degree is preferred

Coordinator, Global Regulatory Affairs Resume Examples & Samples

Maintaining Raw Material and Formula databases
Artwork review of regulatory language against internal standards
Submission of regulatory documentation to external or governmental groups
Representing Regulatory Affairs in meetings with cross functional partners
Submit safety study samples, and track completion dates of studies
Bachelor's Degree in Chemistry, Bio-chemistry, Biology or a related field
0-1 years of regulatory experience in the cosmetics, or consumer goods industries
Strong technical documentation review, evaluation and submission
Experience with launching new products, and consumer good production timetables
Excellent project management, analytical, interpersonal and communications skills

Senior Manager Global Regulatory Affairs CMC Resume Examples & Samples

Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with minimal supervision
As a project team leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle
Independently Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements
Represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
Interacts directly with international Health Authorities, as required
Evaluates change proposals for regulatory impact and filing requirements
Fosters constructive working relationships when interacting with internal and/or external colleagues
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
6 + years pharmaceutical Regulatory CMC experience. Alternatively, 4 + years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired
Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
Demonstrates leadership, problem-solving ability, flexibility and teamwork
Exercises good judgement in elevating and communicating actual or potential issues to line management

Manager, Global Regulatory Affairs Resume Examples & Samples

Minimum Level of Education: Advanced Scientific Degree
Area of Specialisation: General Science or Life Science Degree
Ability to identify and escalate issues to the Global Regulatory Lead and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence
Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams
Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal
Fluent in English, with excellent writing skills
Provide support to the Global Regulatory Lead for key regulatory activities pertaining to a project/product
Interact with (or represents his/her area/product at) internal project related technical teams (e)) and possibly project streams or other multidisciplinary teams, primarily for technical/CMC aspects and possibly for clinical/labelling or procedural aspects as well
Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, primarily for technical aspects and, on occasion, for clinical/labelling/Non Clinical or procedural aspects of given project
Ensure alignment and productive collaboration with the various production sites as appropriate by possibly travel
Provide in-depth input into the asset specific regulatory strategy on a global scale primarily for technical aspects and, on occasion, for clinical/labelling/Non Clinical or procedural aspects
Provide support to the Global Regulatory Lead via critical review of the primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural regulatory documents, Global Regulatory Plans and Key Message Summaries
May fulfil the role of N+1 review as per RSBP primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural-based documents
Provide in-depth input primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural parts of the Global Regulatory Plan (GRP)
Coordinate (primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural sections) and ensure that those documents meet regulatory requirements
Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of primarily for technical and, on occasion, for clinical/labelling/Non Clinical or use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural aspects
May possibly act as the point of contact for Regulatory Agencies for asset(s) (project-specific)
Provide support to the Global Regulatory Lead to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s)
In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her expertise area (primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural)
Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities
Ensure planning and proper organisation of activities (for one of RA specific activities within primarily for technical and, on occasion, for clinical/labelling/Non Clinical or procedural) in line with the overall project plan and RA milestones

Senior Manager Global Regulatory Affairs Resume Examples & Samples

Collaborate with PMRT and execute major US and Global campaigns with some oversight from function head
Execute regulatory activities and provide regulatory support on projects in accordance with applicable US regulations and guidelines. Ensure regulatory compliance of promotional materials generated for assigned products
Be prepared to present to Senior Mgt. and/or present regulatory topics to cross-functional teams as requested
Understand and interpret scientific data as it relates to regulatory requirements and strategy for product promotional claims and unbranded disease awareness activities
Understand broad concepts within regulatory affairs and implications across organization; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies; demonstrates increasing independence
Plan, execute and manage regulatory OPDP submissions for assigned products
Manage other regulatory professionals as assigned. Able to guide and develop direct reports. Identifies and notifies manager of resource gaps for assigned product
Continually review competitive materials and provide assessment to Commercial organization as requested
Interact with FDA to urge enforcement activity as necessary
Serve as the Regulatory representative on responsible product Press Release Working Groups
Assists in the review of licensing opportunities
BS/BSc or BA accepted, RA Masters degree or PharmD preferred
> 5 years industry inclusive of > 3 years regulatory or related experience
Experience in reviewing, authoring, or managing components of regulatory submissions or promotion and advertising materials or related activities
Knowledge of FDA regulations
Understanding of scientific principles and regulatory/quality systems relevant to drug development
Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials
Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes and regulations. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation
Works well with others, especially within cross-functional teams and management of direct reports
Models leaders at all levels daily. Able to bring working teams together for common objectives

Senior Manager, Global Regulatory Affairs Resume Examples & Samples

Bachelor’s degree (or equivalent) required. Masters preferred
10 + years experience in Pharmaceutical industry, preferably with 5 years in Regulatory Affairs, research and development or quality assurance/compliance
Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment
Ability to work independently and focus on multiple issues/deadlines simultaneously
Ability to critically analyze complex and/or ambiguous information and the impact on products and process
Extensive knowledge of communication theory/practice and Business Change Management
Ability to effectively communicate complex issues both verbally and in writing
Experience in the development, implementation and maintenance of a homepages and/or other communication media
Facilitator as well as team player with excellent interpersonal skills
Ability to negotiate and form consensus among various parties important
Systems Knowledge – extensive knowledge of Communication theory/practice and Business Change Management
Regulatory Familiarity – knowledge of global regulatory agencies and regulations relative to activities covered in regulatory affairs in order to facilitate communication activities as relevant
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes
Takeda Operations – in-depth understanding of Takeda’s operating philosophy, structure and methods including a thorough knowledge of the foreign‑owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Communication – ability to express oneself clearly and concisely to a variety of audiences
Team Working - ability to work with team members in a friendly, professional manner
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization

Manager Global Regulatory Affairs Resume Examples & Samples

Lead Maintain Compliance efforts for team and draft/edit corporate policies and procedures and develop compliance programs where necessary
Lead Global Regulatory Affairs (GRA) activities for government agency audits and respond to audit findings
Write corporate policies and procedures and develop compliance programs
Manage government agency audits and respond to audit findings
Support product recalls in cooperation with Quality and lead cross functional efforts where necessary
Act as a peer reviewer for certain high-level regulatory decisions
Monitor and Interpret monitoring and interpretation of current Regulatory Environment and keep abreast of new or revised regulations and analyze and assess impact on company
Educate other team members to new regulations and anticipate necessary adaptations
Monitor the Regulatory Competitor landscape and keep the organization abreast of potential threats and opportunities jeopardizing global development goals
Provide Regulatory Intelligence information to the organization
Monitor the Regulatory Competitor landscape and keep the organization abreast of potential threats and opportunities
Ensure that strategy plans address the needs of GRA team and region
Provide General Regulatory Support and Guidance where needed
Serve in an advisory capacity on project teams
Assess and alert organization to relevant regulatory risks
Assess regulatory implications of various issues as requested
Advise senior management of regulatory issues/risks and leads development of mitigation plans
Ph.D. with six (6) plus years of experience with three (3) years of directly related Quality or Regulatory experience, Master’s Degree with eight (8) plus years of experience with five (5) years of directly related Quality or Regulatory experience, Bachelor’s Degree with ten (10) plus years of experience with seven (7) plus years of directly related Quality or Regulatory experience, or Associate’s Degree with twelve (12) plus years of experience with nine (9) years of directly related Quality or Regulatory experience
Strong working knowledge of Quality System Regulations, Medical Devices Directive, and international electrical safety standards
Strong analytical skills and ability to interpret data and make strategic decisions around regulatory strategy
Must have the ability to work within a global team framework and maintain a global perspective
Demonstrated high performance orientation, detail orientation, organization skills, and market knowledge
Excellent written, listening, and verbal communication skills as well as analytical skills
Business computer skills and business applications
General medical knowledge
Demonstrated strong influencing skills and consensus building skills

Manager, Global Regulatory Affairs, CMC Resume Examples & Samples

Plans, executes and manages regulatory submissions for assigned compounds with appropriate supervision from RA CMC Management
Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements, with appropriate oversight of RA CMC Management
With moderate supervision, represents Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
4 + years pharmaceutical Regulatory CMC experience. Alternatively 3+ years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired
Some experience participating in meetings with Regulatory Agencies preferred
Ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives required
Demonstrates leadership, problem-solving abilities, and exercises appropriate judgment when working with project teams
Exercises good judgment in elevating and communicating actual or potential issues to line management
Excellent written and oral communication skills required
Active participation in Agency/Industry groups/forums preferred

Assoc Dir Global Regulatory Affairs Operations Resume Examples & Samples

Business ownership of Otsuka’s GRA systems (e.g., submission controlled documents, publishing, and labeling, RIM) that serve as the solutions to meet GRA objectives
Manages cross-functional stakeholder and GRA team engagement to ensure planning, implementation, and appropriate use of processes and systems given a strong understanding of regulatory processes
Represents GRA for business case creation, business requirements collections and prioritization, joint system investment opportunities, process improvements, innovations, roadmaps, and change championship
Develops, communicates, and builds consensus for goals and programs that support team and company objectives
Leads the regulatory business teams for responsibilities related to required processes, use, analytical needs, and continuous process improvement initiatives
Executes and oversees the regulatory business strategy, resources, and practices; including, but not limited to Health Authority interactions, submission authoring, and labeling
Represents GRA on corporate and initiative process, people, and technologies workgroups to provide inputs (e.g., evaluations, schedules, budgets, requirements) to achieve measurable business outcomes
Executes corporate objectives to educate stakeholders on GRA business processes, builds consensus for goals and programs, and shares opportunities and improvements
Benchmarks and evaluates the effectiveness of work processes, operational plans and schedules to achieve the agreed program objectives
Makes critical decisions that capitalize on opportunities for optimization and effect positive change
Provides input to mid- to long-range plans to carry out objectives established by group management
Manages adherence to terms and expenditures related to GRA contracts
Educates internal and external stakeholders on relevant systems uses or gain alignment when processes vary
Gather regulatory intelligence and communicate information regarding current activities, trends and changes in the regulatory environment to key stakeholder to enable informed risk-taking
Provides advice and interpretation of relevant quality regulations and guidance to GRA team
Makes key decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management
Contributes to needed GRA G-SOPs, working practices, and instructional guides
Communicates regularly with key firms to keep current on existing and emerging GRA services and capabilities
Liaises with other R&D, IT functions, and among the GRA leads to ensure appropriate use of relevant technologies, consistent and harmonized business processes, and joint development of creative solutions to meet business needs
Participates with key stakeholders and GRA management in the development and implementation of strategic business plans, decisions and recommendations including providing required support or leadership of assigned projects and initiatives
Partners with IT and represents business stakeholders in jointly developing applicable service levels, systems governance, and support plan
Supports or leads other GRA initiatives as assigned
Minimum of 10 years of pharmaceutical industry experience
Minimum of 5 years of regulatory experience
Minimum of 3 years of contract administration
Minimum of 3 years of international or global project/initiative experience
Demonstrated knowledge of business use of regulatory technologies, including Publishing, EDMS, Submission tools, regulatory information management (RIM), and Identification of Medicinal Product (IDMP), and related regulatory requirements
Working knowledge of pharmaceutical industry regulatory-related laws, regulations, and guidance
Solid understanding of the FDA, EMA, and Health Canada organizations, helpful to have knowledge of other health authorities (e.g., PMDA)
Demonstrated knowledge of regulatory requirements as they relate to user requirements, business contributions to validation
Ability to manage and supervise others including managed service providers and vendors
Familiarity with Submissions, Labeling, CMC, medical writing, and promotional compliance components of GRA
Experience working with global multi-lingual teams
Proficient use of Microsoft Office products suite
Results oriented / Innovation: Maintains focus that yields and creative and effective outcomes. Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects
Communication skills: Effective in written, spoke and listening activities. Thoughts are conveyed in a
Clear, concise and timely manner. Must be able to effectively convey complex or difficult information. Listens carefully to understand various points of view and is easy to approach
Problem solving skills: Demonstrates the ability to anticipate and identify core problems, apply insightful analysis, and solve problems effectively. Must be willing to confront tough or difficult issues
Detail Oriented: Demonstrates ability to set and communicate audit goals and standards for Otsuka. Administratively sound in the running of the audit office and meeting Otsuka and industry requirements for reporting. Maintains good records, organized, and timely
Initiative: Must be proactively seeks out and accepts accountability for new and difficult challenges in the field of responsibility
Flexibility: Demonstrates the ability to manage change. Maintains controls for outcomes even when confronted with changes or new direction. Understands that there are often no single right answers
Enthusiasm: Demonstrates a strong desire to accomplish and earn success. Instills a sense of team spirit among peers and team groups. Affects group in a positive manner. Maintains a realistic perspective balanced with strong optimism

Associate Director, Global Regulatory Affairs Resume Examples & Samples

Lead the development, implementation, and influence of innovative CMC regulatory strategy
Identify and assess global regulatory risks and mitigations
Develop global agency meeting engagement plans
Demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork, and communication is a requirement for this role
Support and/or act as the global regulatory contact with relevant regulatory authorities
Coordinate all CMC aspects of global regulatory submissions and submission strategy
LI-GA3

Global Regulatory Affairs Resume Examples & Samples

Works to ensure compliance for the Regulatory Organization, including internal and external teams and partners
Participates in the creation, review, approval and lifecycle management of controlled quality documents (e.g. SOPs) and supporting documents within Global Regulatory Affairs. Ensures internal review of QMS documents from other functional areas
Analyzes and communicates compliance metrics, ensuring communication of oversights. Make recommendations of quality improvements across GRA
Manages overall GRA Training program ensuring development and delivery of training materials describing system related business processes
Plans and ensures end-user training is conducted globally and locally. Ensures appropriate assignment and management if individual training matrices within GRA
Manages Quality Event Investigations and deviations in collaboration with relevant stakeholders establishing effective and timely CAPAs
Partners with R&D QA and interface with all disciplines in the identification and understanding of the interfaces between the different functions in respect to QMS
Maintains awareness of QMS, lead communication efforts to global RA persons on changes/updates to the QMS
Updates and manages QMS information/access sites/portals
Participates in global projects for QMS development and maintenance
Develops and analyzes compliance metrics, and identifies potential improvement activities. Communicates issues/trends to Compliance management
Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to Regulatory Affairs as well as GVP and GCP
Leads/supports GRA in Inspections and audits covering readiness activities, fulfilment of requests and the management of any outcomes
Develops and maintains the GRA Business Continuity Strategy and plan in collaboration with the Leadership and QMS team
Supports overall regulatory intelligence efforts to ensure GRA maintains overall compliance to new and revisions to Global regulatory requirements as they impact GRA
Bachelor’s degree (or equivalent) required. Masters preferred
5 + years experience in Pharmaceutical industry, with 3-5 years in Regulatory Affairs, research and development or quality assurance/compliance
A minimum of 3 years of QMS experience. Experience in the development, implementation and maintenance of a QMS is recommended
Demonstrated knowledge of pharmaceutical and regulatory affairs requirements and practices
Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets
Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment
Ability to work independently and focus on multiple issues/deadlines simultaneously
Ability to critically analyze complex and/or ambiguous information and the impact on products and process
Ability to effectively communicate complex issues both verbally and in writing
Excellent analytical, technical and problem solving skills (TQM or Six Sigma experience preferred
Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties
Systems Knowledge – extensive knowledge of Quality Management Systems
Regulatory Familiarity – extensive knowledge of European, US and international regulations relative to activities covered in regulatory affairs
Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies including Regulatory Affairs processes
Takeda Operations – in-depth understanding of Takeda’s operating philosophy, structure and methods including a thorough knowledge of the foreign‑owned parent company and any affiliates. Ability to work effectively with any internal and external Takeda department
Analytical Skills – ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Communication – ability to express oneself clearly and concisely to a variety of audiences
Team Working - Ability to work with team members in a friendly, professional manner
Knowledge Sharing – ability to capture knowledge within (and from outside) the organization; offer solutions, improve processes and deliverables through use of information; improves information capital by contributing experience, deliverables and models for others to use
Interpersonal Flexibility – ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization

Global Regulatory Affairs & Clinical Safety Quality & Compliance Associate Resume Examples & Samples

Collaboration and Partnering: Effectively partners with others to accomplish quality goals; possesses group leadership skills
Communication Skills: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills. Comfortable facilitating global meetings
Problem Solving: Demonstrates advanced level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction
Strategic Thinking: Effectively applies skills to drive or participate in change efforts to enhance processes within GRACS or across areas within MRL that improve quality and /or add value to the business
Project Management: Demonstrates advanced ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations
Decision Making: Effectively applies skills to utilize knowledge, networks and data to support rapid decision making

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