Associate Director, Regulatory Affairs Resume Samples
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Associate Director, Regulatory Affairs Resume Samples
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GW
G Wisozk
Guadalupe
Wisozk
12517 Frida Loop
San Francisco
CA
+1 (555) 190 4542
12517 Frida Loop
San Francisco
CA
Phone
p
+1 (555) 190 4542
Experience
Experience
Boston, MA
Associate Director Regulatory Affairs
Boston, MA
Skiles-Sporer
Boston, MA
Associate Director Regulatory Affairs
- Work with R&D, Clinical team to assure smooth operation of product development and clinical work to support business growth and development
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment
- Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals
- Provide strategic guidance for product development and planning throughout the product lifecycle
- Develop training programs, approve process and procedural changes. Manage review and approval process for all advertising, labeling and promotional materials
- Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Chicago, IL
Associate Director, Regulatory Affairs
Chicago, IL
Armstrong-Littel
Chicago, IL
Associate Director, Regulatory Affairs
- Manage the internal FDA submission development process for infant formula and work with Sr. Director of Regulatory Affairs in developing responses to FDA
- Provides recommendations on project decisions and makes recommendations for improvements
- Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management
- Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development programs
- Leading and supporting development of project, communication, training, and change management plans
- Develop and implement CMC regulatory affairs strategy to support development programs
- Develop and execute US regulatory strategy and contingencies for assigned projects
present
San Francisco, CA
Associate / Director, Regulatory Affairs
San Francisco, CA
Weimann and Sons
present
San Francisco, CA
Associate / Director, Regulatory Affairs
present
- Contribute to the preparation and editing of clinical trial and marketing applications that include delivery devices
- Successful track record in contributing to/managing cross- functional teams
- Manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitate collaboration
- Computer Proficiency
- Provide regulatory management with draft correspondence for Health Authorities as related to device aspects of projects
- Serve as a medical device and combination product Subject Matter Expert to drug product development and marketed product teams. Provide them with interpretation and application of global delivery device regulations and guidances related to combination products
- Author and review regulatory strategy documentation, including regulatory assessments for device development initiatives and due diligence activities, and clearly communicate recommendations to cross-functional teams and senior management
Education
Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
Northern Illinois University
Bachelor’s Degree in Science
Skills
Skills
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international
- Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-SA
- Demonstrated ability to form strong working relationships across functional boundaries
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
- Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
- Develop and manage regulatory submissions such as 510(k), Investigational Device Exemptions (IDE) and Annual/Periodic Reports to US FDA, and Design Dossier, Technical Files and Notice of Change to EU notified body and other regulatory agencies
15 Associate Director, Regulatory Affairs resume templates
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1
Associate Director, Regulatory Affairs CMC Resume Examples & Samples
- Provide RA-CMC support and advice for all internal activities related to manufacturing, development, control, and quality of commercial and clinical products
- Define and lead the development of high quality regulatory submissions
- Prepare teams for pre-submission meetings with regulatory authorities to reach agreement on complex CMC requirements
- Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with global health authority requirements in preparation for licensure
- Manage, track, and assure accountability to global regulatory CMC commitments
- Minimum of 10 years of industry experience with at least 6 years of Regulatory CMC experience; extensive experience should be in CMC of antibodies, protein therapeutics or other biological products
2
Associate Director Regulatory Affairs Strategy Resume Examples & Samples
- Regulatory Knowledge: Maintains a high level of regulatory knowledge
- FDA Interactions: Acts as single point of contact to FDA for assigned products/projects. Liaises with FDA project manager/reviewers to resolve any potential issues with minimal supervision. Responsible for the appropriate documentation of interaction, decisions and outcomes
- Dossier Submissions: Leads the preparation, coordination or monitoring of US regulatory submissions with supervision. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions
- Registration Strategy: Assists in or leads the formulation of registration strategies for products/projects, depending on complexity
- Team Interactions: Provides US RA representation on project teams. May act as single point of RA contact on cross-functional teams with managerial oversight; begins to foster a global view as a member of the regulatory team
- Experience in the pharmaceutical industry required with 5+ years direct regulatory affairs experience, including US regulatory experience
3
Associate Director, Regulatory Affairs Resume Examples & Samples
- Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures
- Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and subteams
- Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
- Maintains knowledge of highly complex regulatory requirements up to current date, contributes to preparation of new regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management
- Initiates or contributes to local and/or global process improvements which have a significant impact on business
- Excellent verbal, written, negotiation, influence and interpersonal communication skills are required
- Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
- Must be capable of developing and implementing regulatory strategies and of managing complex negotiations with regulatory authorities
- Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
- Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
- Must be capable of effectively leading teams in preparation of submissions
- Schedules and arranges own activities and those of direct reports
- Is recognized as an expert resource for regulatory advice across departments
4
Associate / Director, Regulatory Affairs Resume Examples & Samples
- Author and review regulatory strategy documentation, including regulatory assessments for device development initiatives and due diligence activities, and clearly communicate recommendations to cross-functional teams and senior management
- With regard to devices, ensure regulatory compliance during both pre- and post-marketing. During post approval assure timely execution of maintenance activities, including change controls, annual reports, supplements, and amendments. Proactively identify regulatory issues and risks, including mitigation plans
- Develop and maintain expert knowledge of current global regulatory requirements for medical devices and combination products for initial clearance, registration/CE mark, re-registration and post-approval changes. Identify and resolve technical and operational device problems associated with regulatory strategy and submissions. Collaborates with peers to resolve cross-functional obstacles
- Prepare and coordinate accurate and timely submissions to health authorities (HA), in particular FDA, including strategies to address HA requests and responses for the assigned medical device or device aspect of combination products. Develop innovative and scientifically sound approaches to gain approval and clearance of medical devices and associated products. Regulatory submissions are global and include Investigational New Drug or Investigational Device Exemption applications, 510(k) clearances, Worldwide Marketing Applications and maintenance of marketed products, including post approval submissions and renewals
- Contribute to the preparation and editing of clinical trial and marketing applications that include delivery devices
- Provide regulatory management with draft correspondence for Health Authorities as related to device aspects of projects
- Serve as a medical device and combination product Subject Matter Expert to drug product development and marketed product teams. Provide them with interpretation and application of global delivery device regulations and guidances related to combination products
- Lead and/or participate in cross-functional and regulatory project teams working on developing product claims for labeling and promotion, as well as, commercialization of new devices
- Manage strong network with key stakeholders such as marketing, legal, and other scientific personnel that facilitate collaboration
- Bachelor’s or Graduate degree in the life sciences or engineering or equivalent combination of education and experience
- At least six (6) years of pharmaceutical medical device experience with Class 1 and 2 devices, including combination products
- Strong communication skills in English, verbally and in writing, are required
- Team and customer orientation
- Computer Proficiency
- Ability to accommodate changes and communicate them effectively
- Successful track record in contributing to/managing cross- functional teams
- Demonstrated operational success with device PMAs, 510ks and/or combination drug-device submissions required
5
Associate Director Regulatory Affairs Resume Examples & Samples
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams or any relevant team; assure the progress of projects by providing direction, solutions and feedback to the teams
- Manage meetings with marketing partners, and vendors for their products/projects
- Support the company's commercial products
- Review and approve labeling for the company's products,
- Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy and labeling) including CTAs
- Ensure the timely submission of INDs/CTAs/IMPDs, MAAs/NDAs and variations for their products/projects
- Represent the company in external forum
- Proven development and growth in regulatory roles with increasing responsibility in the pharmaceutical industry
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
- Proven track record of effective collaboration with regulatory agencies
- Demonstrated leadership success in management of regulatory activities
- Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
- Bachelors or Masters or advanced degree in a scientific discipline
6
Associate Director, Regulatory Affairs Resume Examples & Samples
- Author and review CMC regulatory documentation (ie, comparability protocols, validation protocols, and stability protocols) to ensure quality and alignment with regulatory strategy
- Plan and coordinate CMC dossiers for various submission types (e.g., CTD, IND, IMPD, annual reports)
- Review and assess worldwide regulatory impact of CMC changes relating to regulatory filings
- Interact with other disciplines in the review and finalization of CMC reports and summary documents
- Participate on project teams for assigned projects, and serve as a CMC advisor with regard to regulatory requirements
- Prepare responses to health authorities’ review letters, and requests for additional information
- Assure timely continuity of product registration renewals
- Coordinate and manage dissemination of CMC changes to marketing partners and manage health authorities’ review of such changes
- Monitor, review and analyze the development of new requirements and regulations and provide input on their impact on products/projects
- Review and provide an assessment of potential licensing acquisitions relative to regulatory implications and limitations, as required
- Participate in company Advisory Boards, attend congresses and professional meetings, and be a company spokesperson, as required
7
Associate Director, Regulatory Affairs Resume Examples & Samples
- Product registrations /Submissions
- '-Represents Regulatory Affairs at Project team meetings e.g. Brand Teams, Product Workstreams, CMC Workstreams etc) and presents agreed RA position and negotiates with and influences management (Manufacturing, Commercial, QA, Development etc.) to ensure programs meet regulatory requirements
- Participates in agency meetings as appropriate
- Manages the processes to achieve regulatory agency input into projects and programs
- Trains, develops and mentors individuals; may include formal supervisory responsibilities
- Effectively assigns team membership, plans and prioritizes workload, follows up to assure success
- Proactively develops relationships with other groups / departments
- Affiliate Coordination
- Maintains working relationships with defined countries and provides support, help desk, forward planning, workload prioritisation and performance management
- Starts develop relationships and visibility with General Managers and Area Commercial leaders
- Compliance across Life-Cycle
- Maintains an awareness of legislation and assesses its global impact on Abbott business and Abbott
- Manage projects or small/single Therapeutic Area
- Project assignments are both self-initiated and provided by manager
- Provides input into strategic direction
- Works largely unsupervised
- 10 years in R&D or related area
8
Associate Director Regulatory Affairs Resume Examples & Samples
- At least bachelor degree in scientific discipline; advanced degree preferred
- A minimum of 9 years previous pharmaceutical drug development experience, including previous experience in attending and/or helping a team prepare for agency interactions (e.g. FDA advisory committee meetings, Oral explanations, EoP2 Meetings, Scientific Advice, Pre-Submission Meetings, etc), and experience in submissions for PIPs, CPs, and a sound understanding of PRIME, ODD, etc
- Proven record of successful submissions and negotiations with the local authorities in areas of CMC and product formulations, particularly in biotechnology/biological products, and an enthusiasm for competitive developments in new technologies relevant to the oncology landscape
- Recognized as an expert in regulatory aspects of drug development involving undefined frameworks with technical complexity and broad scope
- Scientific knowledge in CMC, general biological/physical science, clinical development, and an ability to apply that knowledge to regulatory issues and product development
9
Associate Director, Regulatory Affairs, CMC Resume Examples & Samples
- Provide CMC RA leadership within RA and on cross-functional teams
- Lead CMC aspects of partnership programs for Halozyme to insure overall CMC strategy is achieved
- B.S. / M.S. / Pharm. D. or Ph.D. in biochemistry, biology, engineering, related pharmaceutical field, or equivalent work experience
- Demonstrated leadership in regulatory strategy and experience in regulatory interaction
- Energetic person with ability to prioritize and work on multiple projects at the same time
- Creative approach to problem solving; ability to deal with ambiguity and declare a clear path forward
- Must have a demonstrated track record of being results driven
- Strong leader who works through the team to prioritize and achieve milestones
- Strong business acumen, with the ability to balance business and staff development needs
10
Associate Director, Regulatory Affairs Resume Examples & Samples
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
- Demonstrated effective leadership, communication, interpersonal and negotiating skills
11
Associate Director, Regulatory Affairs Resume Examples & Samples
- Responsible for the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using electronic document management systems, as appropriate
- Author, review, compile, and submit new applications, supplements and amendments and periodic reports, as well as responses to Health Authorities in US and Canada as needed
- Implementation of robust Regulatory Strategy and Tactical plan for US and Canada Regions on the assigned projects
- Responsible for managing complex issues and providing US strategic support for to assigned projects
- Responsible to ensure regulatory commitments are met for assigned projects
- Independently manages projects and is responsible for managing timelines with minimal supervision
- Provides recommendations on project decisions and makes recommendations for improvements
- Communicates to manager any issues that would result in a delay
- Communicates directly with FDA and manages FDA meetings as a company liaison for assigned projects
12
Associate Director, Regulatory Affairs Resume Examples & Samples
- Execute regulatory strategies by leading the review of registration dossier for new registration submission and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
- Collaborate with internal and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance
- Manage execution of registration documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
- Identify, communicate and escalate potential regulatory issues to regional and global RA management, as needed
- Bachelor.Sc. in Pharm
- At least ten (10) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields
- The candidate must be proficient in English
13
Associate Director, Regulatory Affairs Resume Examples & Samples
- Collaborate with Merck Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance
- Identify, communicate and escalate potential regulatory issues to Global Regulatory Affairs and Clinical Safety CMC management, as needed
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields
- Ability to lead a team of matrixed colleagues to deliver on business commitments and project timelines
14
Associate Director Regulatory Affairs Resume Examples & Samples
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration
- Assists in the coordination of projects and resources, ensuring quality deliverables to customers
- May have financial responsibility and accountability for one or more Regulatory Affairs sites. Undertakes business development activities and monitors growth and performance, as required
- May undertake risk analysis and manages the outcome as appropriate
- May manage meetings with Regulatory Agencies
- May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations
- Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
- Line management experience required, with demonstrated success in staff development, engagement, and performance
- Ability to manage competing priorities, as appropriate
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with staff and customers
- Sets a positive example to more junior staff relating to professionalism, positive attitude and communication style to customers and colleagues. Communicates effectively and confidently with various levels of the organization, as appropriate; remains motivated and enthusiastic in times of change and other pressure situations
- Ability to exercise independent judgement taking calculated risks when making decisions
- Sound financial awareness
15
Associate Director, Regulatory Affairs Resume Examples & Samples
- Responsible for defining and implementing regional regulatory strategies (primarily EU), including filing of regulatory submissions for assigned programs
- Leading regional filings (MAA, ODD, PIPs)
- Lead health authority meetings (Scientific advice, PIP clarification, Rapporteur meetings, Pre-submission, oral explanation, SAG etc.)
- Secure alignment across function and with partners
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
- Define and ensure execution of regional labelling strategy, taking global labelling strategy into consideration
- Provide regulatory guidance to company personnel throughout the research and development process
- Direct the preparation of clear and effective submissions
- Prepare and deliver effective presentations for external and internal audience
- Monitor and analyse appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
- Provide input to regulatory senior management teams as required
- Represent a regional strategy to a global organisation
- LI-EU4
- Minimum of 5 years Regulatory experience
- 10 years pharmaceutical/biotechnology industry experience
- Experience of leading major regulatory submissions (MAAs), Line extensions, New Indications (preferably via the Centralised procedure), leading agency scientific advice meetings
- Solid knowledge of applicable regulations
- Experience in interpretation of regulations, guidelines, policy statements, etc
- Direct experience in interfacing with relevant regulatory authorities
16
Associate Director, Regulatory Affairs Resume Examples & Samples
- Develop and implement CMC regulatory affairs strategy to support development programs
- Plan regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies
- Serve as regulatory representative for select product development programs, including regulatory liaison with business partner(s), the FDA and other regulatory agencies
- Manage relationships with business stakeholders with responsibilities in process development, analytical development and quality to provide CMC regulatory support
- Conduct regulatory risk assessments including risk mitigation
- Lead cross-functional team to develop technically complex regulatory submissions
- Review technical reports and summary documents (CMC) for adherence to regulatory guidelines, strategies, and commitments
- Recommend regulatory policies to assure adherence to FDA requirements. Contribute to the modification, development and implementation of company practices and policies for Regulatory Affairs
- Provide regulatory expertise and policy support; educate others on regulatory policy and environment and impact to internal organization
17
Associate Director Regulatory Affairs CMC Resume Examples & Samples
- Partner with R&D, QA, Operations, Business Units and others to develop regulatory strategies for submissions and product related activities
- Negotiate with regulatory agencies to establish submission strategies and gain approvals of applications
- Point of contact between regulatory agencies and J&J Consumer for chemistry, manufacturing and controls (CMC) related issues
- Preparation, review, submission, approval and maintenance of CMC sections for regulatory filings (CTA’s, INDs, NDA’s/ANDA’s, 510k’s, MAA’s, variations, renewals, etc…)
- Review post-approval changes and assess the regulatory impact on affected registrations. Develop regulatory strategies and coordinate filings (e.g. NDA supplements, Variations) as appropriate
- Act as a liaison between regulatory agencies and J&J Consumer for chemistry, manufacturing and controls (CMC) related issues; point of contact for Health Authority reviewing chemists and supervisory chemists
- Sponsor with R&D leaders to refine/develop processes relating to regulatory submissions and regulatory aspects of product development
- Train and educate colleagues with respect to regulatory requirements
- Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies
- Understands the regulatory landscape across an assigned area of business
- Evaluate and provide opinions regarding agency initiatives and support team efforts to prepare company responses as appropriate
- Propose strategies to resolve routine and more complex regulatory CMC issues
- Represent company in industry organizations, seminars, workshops, etc
- May be asked to manage CMC resources (internal and external) as needed to ensure business continuity, growth, and favorable regulatory compliance profile
- A minimum of a Bachelor’s Degree in Chemistry, Pharmacy or related scientific field is required
- 8+ years of relevant regulatory CMC experience including: preparation of CMC sections for HA filings (Modules 2 and 3, CTD, e-CTD), maintenance and experience with global regulatory filings is required
- Working knowledge of regulatory requirements for various drug dosage forms including solids, semi-solids, solutions, sterile products, etc. is required. Experience with devices is preferred
- CMC experience with small molecules desired
- Experience across one or more consumer product categories (drugs, cosmetics, devices) preferred
- Expertise regarding documents needed to support local, regional and global filing requirements is required
- Strong technical/science-based background (QA, mfg, lab, plant, etc.) highly desired
- Broad and thorough knowledge of GMP and regulatory compliance is required
- Travel up to 10% domestic and international may be required
18
Associate Director, Regulatory Affairs Resume Examples & Samples
- Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions and feedback to the teams
- Lead regulatory interactions with health authorities, marketing partners, and vendors for their products/projects
- Support the company’s commercial products
- Review and approve labeling for the company’s products
- Ensure the timely submission of INDs, NDAs, amendments, and supplements for their products/projects
- Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization
19
Associate Director, 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
- 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
- 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
- Active participation in Agency/Industry groups/forums preferred
20
Associate Director, Regulatory Affairs Resume Examples & Samples
- Independently handles personnel issues, conflict management, defines goals that increase knowledge and skills of staff, and defines staff expectations, without involvement of senior managers
- May contribute to discussions on implementation of business strategy on a regional basis and will set and implement site-specific objectives, as appropriate. Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives
- Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs
- May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation. May provide strategic regulatory and/or technical consultancy on a variety of projects
- May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
- May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
- Performs other duties, as business needs require
21
Associate Director Regulatory Affairs Resume Examples & Samples
- Coordination of the global roll-out of any new product dossier (and variation with global impact) to regions and countries taking into account the local regulatory requirements
- Strong role in the submission strategy for new product dossiers/global variations in alignment with other GRA teams and other stakeholders (e.g. global commercial and regional management)
- Close collaboration with regional RA coordinators on key projects and business opportunities
- Executing central and non-central European licensing procedures (new licensing/maintenance)
- Establishment and maintenance of contacts between MSD AH and EU regulatory authorities
- Advising on regulatory requirements and contributing to the implementation of regulatory strategies to new product developments and existing product licenses
- Advising global commercial, global R&D and our national regulatory affairs colleagues in the interpretation and application of veterinary regulation
- Manage data and information in an electronic environment, e.g. submission- and regulatory database management
- PhD. (or MSc. + experience) in life sciences (Veterinary Medicines , Pharmacy or Biology)
- Knowledge of research, production and/or control of veterinary products is an advantage
- Minimal of 4 years of experience in the licensing of pharmaceuticals and biologicals/vaccines (preferably for veterinary medicinal products) in EU and/or International regions
- Fluent in English in speaking and writing and preferably a thorough command of a second European language
- Team player and able to work with specialized international teams
- Able to analyze complex situations and find adequate solutions
- Experience in project management is an advantage
22
Associate Director Regulatory Affairs Resume Examples & Samples
- Bachelor’s degree (or equivalent); Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
- 5-7 years’ experience in a regulated industry
23
Associate Director, Regulatory Affairs, CMC Resume Examples & Samples
- A Bachelor’s degree is required, preferably in Pharmacy, Chemistry, Biology or a related science/technical field
- A Bachelor’s degree with 10+ years of pharmaceutical or medical industry experience OR a Master’s degree with 8+ years of pharmaceutical or medical device industry experience OR a PhD with 5+ years of pharmaceutical or medical device industry experience is required
- An advanced degree in a technical or engineering discipline is strongly preferred
- At least 5 years of experience in Regulatory Affairs, Quality, and/or R&D in the medical device or drug delivery device industry is required
- Direct experience in the preparation of medical device PMAs, 510(k)s, IDEs, MAFs, CE Mark Technical Files, AND/OR NDA/BLA/MAA ICH eCDT Module 3 delivery device sections is required
- Strong writing skills are absolutely essential
- Significant knowledge of device regulations [i.e., 21 CFR Parts 3, 4 and 800, QSR (Design Controls), European Medical Device Directive, ISO technical standards (ISO 11608), CE Marking, device complaint handling/MDRs, human factors testing, and device risk analysis (ISO 14971] is strongly preferred
- This position is located in Malvern, PA, Spring House, PA, Titusville, NJ, Raritan, NJ, or Fremont, CA, and may require up to 10% travel
24
Associate Director, Regulatory Affairs Resume Examples & Samples
- Develop and manage regulatory submissions such as 510(k), Investigational Device Exemptions (IDE) and Annual/Periodic Reports to US FDA, and Design Dossier, Technical Files and Notice of Change to EU notified body and other regulatory agencies
- Responsible for maintaining global regulatory technical files/dossiers/registrations as required
- Responsible for the timely production and submission of regulatory documentation, including 510(k)s and Investigational Device Exemptions (IDE) in compliance with regulatory agency requirements
- Review, interpret, and advise internal stakeholders on regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
- Act as core member on project teams to provide regulatory guidance and strategic regulatory planning in support of new product development and existing product support
- Support interactions with regulatory authorities, including overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up
- Participate in inspections/audits by the notified body or other international regulatory agencies to include US FDA by producing requested documents or answering any inquiries for information
- Provide critical review of documents for devices and drug-device combination products (e.g., design control, technical file, dossier, registration, pharmaceutical packaging and related scientific/technical concepts and techniques, as necessary)
- Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent as well as knowledge of therapeutic area
- Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development programs
- Interface with cross-functional teams (CMC, Nonclinical, Clinical, Commercial) to define contributions to submissions for regulatory submissions
- Interface with global regulatory authorities, strategic partner(s), and consultants
- Bachelor’s degree in a scientific discipline, Advanced degree (PhD, MS) preferred
- 5+ years of regulatory experience in the medical device industry, with proven track record of successful submissions to FDA of IDEs, 510(k)s. and/or PMAs required. At least 3 years of regulatory affairs with experience associated with global submissions
- Must have comprehensive understanding of global regulatory requirements for registration, development and approval of investigational products
- Knowledge of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable for this position
- 510k Submission experience preferred
- Strong interpersonal, communication, and leadership skills
- Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
- Demonstrated leadership and people management skills in team and departmental settings
- Excellent organizational, prioritization and planning skills. Ability to work independently on projects and initiatives internally and with external vendors
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Associate Director, Regulatory Affairs Resume Examples & Samples
- The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development, but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy
- The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meeting and major (issue driven) ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks
- The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels
- The GRTL, working with the regions, will also interact directly with HAs as needed for the project
- The GRTL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed
- Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations
- The GRTL will line manage, and/or coach mentor, junior staff supporting the program
- 7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Experience in other relevant functions will be considered. Delivery of at least one major application (NDA/BLA/MAA/JNDA etc…), or extensive experience with late stage development/marketed products. BS in a scientific discipline
- Extensive knowledge and understanding of complex medical and scientific subject matter as well as evolving FDA policy and guidance related to advertising and promotion topics
- Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
- Excellent operational skills including planning, organizing and ability to motivate and lead others
- Can demonstrate solid oral communication and writing skills
- Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
- Develops collaborative relationships to facilitate the accomplishment of work goals
- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
- Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
- Can build networks to obtain cooperation without relying on authority
- Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-SA
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Associate Director Regulatory Affairs Resume Examples & Samples
- Identify, hire, train, mentor and manage Regulatory Affairs for the pharmaceutical products. Work with President of QA/RA to set department goals, monitor progress, and identify opportunities for career development of staff
- Facilitate communication between QA Managers, Directors and Specialists and their respective divisional personnel to assure regulatory compliance for entire company. Interface with the drug manufacturing facilities to assure compliance and synergies
- Assure all internal and external customers receive outstanding service from department. Serve as Government Liaison to assure all necessary personnel are kept up to date on new, changed or pending regulations
- Develop training programs, approve process and procedural changes. Manage review and approval process for all advertising, labeling and promotional materials
- Direct regulatory for new drug product development. Assure proper systems are in place to facilitate as smooth and efficient process for new products and services
- Work with R&D, Clinical team to assure smooth operation of product development and clinical work to support business growth and development
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Provide leadership and regulatory guidance and insights to the U.S. Nestle Infant Formula business
- Partner cross functionally with Marketing and Product development to proactively identify and create opportunities for innovative product claims and positioning and influence the business strategy
- Ensure that products are in compliance with local regulations with respect to product labeling and design
- Ensure that all product claims and marketing materials are in compliance with local regulations, consistent with global policies, and are appropriately substantiated and documented
- Ensure compliance of product formulations and ingredients nutrition information, and claims
- Provide regulatory interpretation and guidance cross functionally to the business; specifically to product design, food ingredient approvals and marketing for appropriate product claims and advertising
- Identify, assess and clearly communicate to the business any regulatory risks as well as recommended actions
- Participate in the regulatory process and help influence key regulation and guidance
- Manage the internal FDA submission development process for infant formula and work with Sr. Director of Regulatory Affairs in developing responses to FDA
- Advise on regulatory aspects of factory controls and testing as well as product variances and compliance criteria
- 8+ years of experience with regulatory compliance or regulatory affairs management
- Regulatory Affairs, Nutrition, or R&D experience within the Infant Formula industry preferred
- Knowledge of global regulatory requirements is desirable
- Up to 10% domestic and international travel
- People management experience
- Strong project management, technical and communication skills
- Very solid communication and negotiation skills
- Proactive, accountable and forward thinking
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Associate Director, Regulatory Affairs CMC Resume Examples & Samples
- Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal
- Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems
- Deliver all regulatory milestones for assigned products across the product lifecycle
- Identify, communicate and escalate potential regulatory issues to Global Regulatory Affairs and Clinical Safety (GRACS) CMC management, as needed
- The candidate must be proficient in English; additional language skills are a plus
- Technical Skills
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Associate Director Regulatory Affairs CMC Resume Examples & Samples
- A minimum of 3 years of experience in Regulatory Affairs-CMC is preferred
- Direct regulatory experience with CMC documentation preparation for INDs, NDAs, IMPDs, MAAs and global dossiers is preferred
- This position will be based in Fremont, CA, Titusville, NJ, Raritan, NJ or Beerse, Belgium, and requires up to 5% travel, both international and domestic.000019I2
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Participation in the authorization process to prioritize submissions
- In depth knowledge of global CMC guidelines regarding post approval changes
- Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines
- Development and execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines
- Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply
- Lead authoring of clear, concise and effective global post approval submissions according to defined timelines
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
- Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed
- Occasional travel to manufacturing sites may be required
- Minimum of 5 years of CMC experience (technical or regulatory)
- Proficient in M.S. Word
- Adept at use of assessment, planning and tracking systems
- Capability to work effectively in matrix organizational structures
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment); new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide
- Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team
- Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management
- Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems
- Ensures consistency in practices, champions best practices and promotes operational excellence
- A minimum 5 years of Industrial/regulatory experience in biologics research, development and/or manufacturing
- Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience
- Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner
- Strong listening skills
- Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Develops the RA CMC strategy for project teams which incorporates the optimal CMC regulatory pathway based upon comprehensive understanding of regulatory requirements as they apply to the registration, development and approval of investigational biologic products as well as life-cycle management of post approval changes to marketed biologic products
- Serves as a scientific, technical and regulatory CMC expert to project teams for the solution of complex technical issues based upon scientific knowledge and experience in past regulatory precedent through the maintenance of scientific knowledge in the following areas for recombinant proteins, monoclonal antibodies, antibody-drug conjugates and gene/cell therapeutics: molecular genetics and cloning techniques, cell line generation and cell culture techniques, characterization and purification techniques for biologic products, biological product manufacturing processes to include fermentation, purification, viral clearance methodologies, sterilization processes, lyophilization and analytical quality control strategies and methodologies
- Leads all aspects of CMC health authority meetings to include: serves as the primary company liaison for interactions with regulatory health authorities (e.g., FDA, EMA, Health Canada) for CMC issues to include pre-IND, EOP-2, pre-NDA, Type C meetings and Scientific Advice meetings; identifies critical issues with the development team for discussion with the health authority; leads the preparation/review and finalization of the briefing book; prepares the development team for the health authority meeting; leads the health authority meeting; leads the preparation and finalization of the meeting minutes
- Develops the submission content template and leads development teams in the preparation of CMC regulatory submissions-i.e., INDs/IMPDs/CTAs/Amendments/MAAs/BLAs and DMFs to include scientific and technical review for accuracy, soundness and regulatory appropriateness. In addition, supports clinical trial through review of Investigator Brochure, Pharmacy Manual, clinical trial supply labeling
- Serves as the RA CMC representative for the following activities: due diligence in-license opportunities, pre-approval inspections, support of ICH/PhRMA/EFPIA/USP initiatives
- Determines the filing category and content requirements, and leads the preparation of post-approval submissions-i.e., DSURs, Annual Reports, Supplements/Variations to assure maintenance of regulatory compliance and market supply
- 7+ years in the biopharmaceutical industry with significant experience in scientific/regulatory fields
- “Hands on” related biopharmaceutical experience and actual regulatory CMC experience in CMC related activities for recombinant proteins, monoclonal antibodies, antibody-drug-conjugates and gene/cell therapeutics
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Reviews and provides technical advice to prepare regulatory submissions
- Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and clinical development strategy for their products, including post-approval strategies
- Provides project specific regulatory strategy, technical expertise and co-ordination oversight for key client projects
- Ensures quality performance for key/managed projects
- Serve as key clients “Executive” contact person for all issues including attendance at Regulatory Authority meetings
- Manages project budgeting/forecasting including creative input as to allocation of resources, respond effectively to project evolution and changes
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaise with Commercial Finance to follow through on all aspects of contract modification
- Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
- Contributes to development & implementation of Global/regional function plans
- Interacts frequently with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and contractual clarifications
- Leads briefings and technical meetings for internal and external representatives
- LI-SH1
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Leadership in Regulatory Affairs and Compliance
- Regulatory representative during FDA, Notified Body, and external agency inspections
- Impactful communications with regulatory agencies
- Problem solving and resolution as well as complaint and product failure investigations
- Monitor and trend staff performance
- Manage regulatory staff of up to 5 direct reports. Assure resources are aligned to support the regulatory requirements of multiple key Halyard Health medical device businesses and establishments
- Coordinate the timing, preparation, and submission of domestic and international regulatory filings
- Provide leadership to ensure that Regulatory Affairs attracts, develops, and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results
- Provide scientific and regulatory consulting services to regions, business units, and new product development teams and liaise with key healthcare and regulatory experts
- Serve as consultant and advisor to management and project teams on compliance with applicable regulations. Monitor changes to domestic (federal & state) and international regulations that may impact Halyard businesses and oversee strategies to manage required change
- Collaborate with Medical Sciences, Clinical Research, Product Safety, Product Development, and Quality Assurance staff to ensure development of safe and efficacious products
- Ensure that all matters within the incumbent's area of responsibility which could adversely impact the business of the Corporation are communicated in a timely manner
- The incumbent should the a minimal of four-year technical degree and a minimum of 5-10 years or equivalent of relevant regulatory experience; in-depth knowledge of applicable regulatory law; knowledge of quality and business processes, and excellent communication skills. The position requires an individual with the experience interfacing effectively with domestic and international regulatory agencies. An advanced degree (MS, MBA, PhD, JD, MD), ambulatory infusion systems, and/or regulatory affairs certification is highly preferred
- Experience should include in-depth knowledge of domestic (FDA) and international regulatory requirements and medical device registrations, design control activities for medical devices, as well as direct management of FDA and Notified Body inspections. Strong communications (written and oral), analytical, quantitative and problem solving skills are required
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Manage projects related to regulatory CMC deliverables and submission timelines as the primary responsibility. The candidate may also manage 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)
- Track project deliverables through appropriate tools and framework; report to all project stakeholders
- The candidate may be required to travel to other Merck sites on a periodic basis.**
- Knowledge and experience 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
- Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Provide regulatory and lean principle guidance to assure all regulatory processes effectively help drive the objectives of HYH Health Care
- Coordinate the timing, preparation, and submission of regulatory filings. Provide regulatory and regulatory process improvement services to regions, business units, and new product development teams and liaison with key healthcare and regulatory experts
- Provide greater efficiencies to current regulatory affairs processes that include regulatory review of change control, management of regulatory standards, and verification of practitioner/customer facility licenses
- Manage the regulatory staff responsible for verifying customer licenses
- Serve as consultant and advisor to management and project teams to help assure compliance with applicable regulations
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Associate Director, Regulatory Affairs CMC Resume Examples & Samples
- Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects
- Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of Merck pharmaceutical products worldwide
- Conduct all activities with an unwavering focus on compliance
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Ability to identify, define, plan, and project manage the execution of large-scale process re-engineering initiatives across GRACS, including facilitation of strategic planning sessions and leadership of initiatives
- Leading and facilitating large and small-scale business process mapping sessions while working with process owners and functional SMEs to ensure processes meet business and compliance requirements. Document agreed upon processes or process changes working with Business Documentation Leads as required
- Leading and facilitating Business Process Forums (BPFs) and working with stakeholders to identify and prioritize projects within assigned process space(s). Ability to project manage and/or coordinate multiple smaller projects conducted within the Regulatory Affairs and CMC Process Portfolio
- Developing and presenting business case(s) to the Business Process Council and Portfolio Management Team to establish sponsorship and stage projects within overall GRACS change portfolio
- Working with subject matter experts to ensure processes are consistent with current Health Authority (HA) regulations and policies
- Ensuring adequacy of process documentation output, including SOPs, Process Maps, RACI charts, and Execution Resources
- Leading and supporting development of project, communication, training, and change management plans
- Supporting development and implementation of process metrics and control plans
- Must have a working knowledge of the processes, systems, and business requirements within Regulatory Affairs and/or CMC as it relates to product development, manufacturing, registration, post-marketing activities and lifecycle optimization
- Experience facilitating workshops and focus groups with demonstrated experience assessing and enabling process change
- Strong skills in process mapping
- Strong analytical skills with a demonstrated ability to extensively analyze business processes and workflows
- Skilled in the management of project plans and executes with a sense of urgency
- Ability to lead by influence and work effectively in matrix organizational structures
- Demonstrated Change Management Knowledge
- Process Management Knowledge
- Ability to function at a high level of autonomy
- Excellent facilitation, project management, problem solving, and written and verbal communication skills, including presentations to senior management
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Associate Director Regulatory Affairs Resume Examples & Samples
- Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products
- Provides guidance on regulatory requirements and strategies to product development project teams
- Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders
- Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals
- Directs staff in implementing regulatory strategy and preparing regulatory submissions
- Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences
- Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence
- Performs related functions and responsibilities, on occasion, as assigned
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Performs other related duties and responsibilities, on occasion, as assigned
- Bachelor's Degree (BS, BA) ( technical discipline preferred) with a minimum of 12 years’ experience. Master’s or doctorate degree preferred
- Minimum 10 plus years of progressive work experience in regulatory affairs or a related discipline in the medical device field
- Minimum five years of demonstrated experience at a supervisory/managerial level
- An advanced credential in a relevant discipline/concentration
- Ability to multi-task, prioritize and meet deadlines in timely manner
- Ability to plan strategically and work independently
- Strong organizational, planning, and follow-up skills and ability to hold others accountable
- Ability to travel approximately 15-25%, including internationally
- Prior experience in medical device and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc., are preferred
- RAPS certification, preferred
- Experience working in a broader enterprise/cross division business unit model preferred
- Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
- Ability to work effectively within a team in a fast-paced changing environment
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC
- Lead global and/or regional regulatory team on assigned projects
- Develop and execute US regulatory strategy and contingencies for assigned projects
- Serve as the primary interface for FDA on assigned projects
- Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross- functional teams to define contributions to submissions. Lead regulatory submission teams for projects assigned
- Prepare project/study team for FDA and other regulatory health agency meetings, as required
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Development Teams and Study Teams, etc
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred
- Experience in multiple phases of development in various therapeutic areas. Experience in oncology and hematology diseases a plus
- A minimum of 7 years pharmaceutical industry with a minimum of 5 years in regulatory affairs. Global experience desirable
- Thorough knowledge of the drug development process, with a focus on IND and NDA processes
- Demonstrated experience in preparing new IND and/or NDA submissions
- Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy
- Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for attention to detail
- Domestic and occasional International travel may be necessary
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Assist Global Head, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies)
- Manage/oversee assembly and submission of applications to competent authorities
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
- Keep abreast of, interpret and communicate applicable regulatory agency regulations and statutes with internal departments and ensures Novella compliance
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
- Participates in business development activities to grow Novella business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
- Directs the performance of the regulatory affairs staff. Develops project timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks. Assesses performance and recommends salary adjustments
- Extensive knowledge of clinical research and product development life cycles for investigational and marketed health care products
- Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
- Ability to read and synthesize technical material and to prepare clear and concise written documents
- Comprehensive knowledge of US Good Clinical Practice (GCP), ISO 14155-2011 (GCP), Good Manufacturing Practices (GMP),Quality Systems Management (ISO 13485) and Good Laboratory Practices (GLP) requirements,
- Demonstrated experience in client service in the clinical research business
- Demonstrated ability to motivate, lead, and grow a regulatory affairs team
- Extensive demonstrated experience directing and supervising staff
- Demonstrated high energy level
- Ability to handle multiple tasks and challenges simultaneously
- Demonstrated ability to form strong working relationships across functional boundaries
- Exceptional ability to conceptualize, develop and manage timelines
- Ability and willingness to travel internationally
- Ability to travel internationally
- Very limited physical effort required to perform normal job duties
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Associate Director, Regulatory Affairs Resume Examples & Samples
- Lead regulatory interactions with health authorities, manage document preparation, coordination rehearsals and minutes
- Review and approve labelling for the company's products
- Review of protocols, Investigator Brochures, IND/IMPDs, reports and all types of regulatory documentation (quality, safety, efficacy and labelling) including CTAs
- May manage junior regulatory professional
- Experience with regulatory agency interactions and preparation of documentation to support interactions
- Possibly leader in agency interactions
- Knowledge of and possibly experience of special consideration opportunities WW
- Knowledge of international (WW) regulatory affairs (demonstrated by above)
- Experience in preparation of Regulatory strategies
- Experience with maintenance of regulatory authorizations in at least one region
- Experience with supporting a project with development activities in at least two regions
- Experience with working on early development projects (FIM)
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- Excellent verbal and written English and communication skills
- Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical industry
