Regulatory Strategy Resume Samples

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A Little

Archibald

Little

77316 Theresia Village

San Francisco

+1 (555) 801 7635

77316 Theresia Village

San Francisco

Phone

p +1 (555) 801 7635

Experience Experience

Philadelphia, PA

Director Global Regulatory Strategy

Philadelphia, PA

McDermott, Parisian and Monahan

Philadelphia, PA

Director Global Regulatory Strategy

Keep abreast of changes in the Regulatory environment for the project to anticipate necessary adaptations
Ensure early identification of major Regulatory Issues relating to clinical, technical, strategic or operational information impacting successful Clinical Trial Authorizations, and/or Marketing Authorizations Applications/approvals for assigned projects
Communicate and manage these regulatory measures in all major all major global markets via the Regulatory Core Team members and/or local Bayer regulatory departments
Provide regulatory advice on clinical trial design based on competitor intelligence and guidelines and Agency meeting strategy for evaluation of major clinical trials
Make decisions on all key development questions as member of the project team (as all decisions impact the Regulatory dossier and approval processes, i.e. preclinical and clinical study and program designs, licensing, etc.)
Represent Global Regulatory Affairs at major Board of Health (BoH) meetings for assigned projects (GRS who is GPT member as well as Regional GRS)
Lead a global regulatory team (GRT) and coordinate world-wide regulatory input into the global development plan for assigned projects

Houston, TX

Associate Director Global Regulatory Strategy

Houston, TX

Pagac-Willms

Houston, TX

Associate Director Global Regulatory Strategy

Responsible for developing the global target labeling in close cooperation with GPT and RA Global Labeling
Develop the global target labeling in close cooperation with GPT and GRA Global Labeling
Participate in Global Project Team and working groups
May participate in Global Project Team and working groups
Act as the primary interface between Bayer and the local Health Authority (HA), e.g., FDA in the US, EMA in Europe
Develop the local regulatory project goals from development through life cycle. Contribute to global regulatory strategy and project goals
Participate on and may lead a global regulatory team (GRT) and provides local regulatory input into the global development plan for assigned projects

present

San Francisco, CA

Senior Director Global Regulatory Strategy

San Francisco, CA

Jacobson, Koepp and Boyer

present

San Francisco, CA

Senior Director Global Regulatory Strategy

present

Develop the initial target labeling (and competitor labeling) in close cooperation with GRA Global Labeling
Lead the development of the Briefing document for the Health authority meeting
Achieve assigned regulatory project goals, milestones and labeling, from development through life cycle
Review promotional material on global level (Interface to promotional integration team)
Coordinate the activities of a small group of Global Regulatory Managers assigned to major development projects
Represent worldwide Regulatory Affairs on assigned Global Project Teams or represent a region in close cooperation with the Global Regulatory Strategist (GRS) who is the Global Project Team (GPT) member
Own and voice the Regulatory Risk assessment in alignment with GRA management

Education Education

Bachelor’s Degree in Business

Adelphi University

Bachelor’s Degree in Business

Skills Skills

Extensive experience working in investment banking and management consulting specifically in risk, regulatory and strategy arenas
Experience of credit risk
Strong financial product knowledge including over the counter derivatives, corporate loans, securitisations, securities lending, equities and fixed income & currencies
Expertise and experience in regulatory strategy and business planning
Experience of developing Basel II and III and risk weighted assets review and testing procedures
Experience of preparing board level presentations and papers
Excellent Microsoft Office Suite, SQL, Excel, PowerPoint and SharePoint skills
An excellent strategic thinker, with the ability to understand broad business issues and their strategic implications and to make sound business recommendations
Strong intellect, with the ability to deal with complex and ambiguous situations and challenge relevant content from others
An understanding of core banking issues relevant to banking and bank regulation including Internal Capital Adequacy Assessment Process (ICAAP)

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Supervisory Regulatory Strategy Analyst Resume Examples & Samples

Reviewing supervisory letters and documentation to extract key themes and issues
Cataloging and monitoring the cataloging of regulatory issues into appropriate systems
Overseeing and executing on document management: ensuring letters are filed in right places and key stakeholders have access to the documents
Maintaining firmwide regulatory calendar of key meetings and exams
Communicating across Functions and LOBs on regulatory matters
Preparing presentations and compiling large amounts of data into key themes and reports
Assisting on special projects, as needed
Results-oriented, detail-oriented
Excellent quantitative, analytical and communication skills. Ability to work well under pressure and within tight deadlines as well as aptitude to synthesize large amounts of information and develop innovative solutions
Highly adaptable, able to manage multiple projects/deliverables independently and ready to assume a high level of responsibility in a team setting
Team player with a strong sense of urgency and excellent work ethic
Demonstrated advanced proficiency in Microsoft Excel and PowerPoint essential

VP, Regulatory Strategy & Engagement Resume Examples & Samples

Support Regulatory Strategy and Engagement team lead by helping to ensure regulatory scope coverage, which covers six core rules and 13 supplemental guidance documents, and manage the associated supporting and evidentiary documentation
Generally lead stakeholder reporting (IHC Board, Risk and Capital Committee, etc) and communication to ensure a consistent view to all stakeholders on regulatory progress, MRA tracking, gap closure, etc
Identify and escalate issues that may arise during the project lifecycle (i.e., from analysis and design, through adoption of new capabilities)
Collaborate with workstream and project leads to ensure consistent quality management across projects and resolution of routine challenges and issues
Support the coordination CCAR test run
Primary coordination point with implementation efforts for regulation, the internal TRANSFORM agenda, structural reform, among other regulatory and internal structural initiatives
Bachelors degree (BA/BS)
5+ years of demonstrated track record in regulatory projects
5+ years of Product/business experience covering various Markets/IBD businesses
Demonstrated track record in regulatory projects
Strong PC skills (Microsoft Suite including Excel, Word PowerPoint and Visio)
Ability to understand and deal with competing priorities
Ability to be able to take initiative, analyze, summarize, and communicate effectively both in writing and orally
A strong, polished presence and ability to challenge opinions with confidence, integrity and professionalism

EU Regulatory Strategy Product Lead Resume Examples & Samples

Accountable for defining the EU regulatory strategy for assigned products (maintaining and extending Shire product registrations in EU markets). Collaborates closely with all other key GRA stakeholders (including but not limited to, advertising and promotion, labelling, CMC, regulatory operations, international regulatory team and regulatory staff in the EU LOCs) to ensure that all aspects of the regional strategy is coordinated and considered
Under direction of Head EU Regulatory Strategy Group, designs EU regulatory strategies in close collaboration with GRL to obtain, maintain and extend Shire product registrations in Europe
Provides regional regulatory expertise and works in close collaboration with the GRL in organizing and providing support to meetings with European Health Authorities
Responsible for mentoring junior members of the regulatory team. As required by the business, may have opportunity to have line-management responsibility of EU Regulatory Product Specialists
Ensure appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency, SwissMedic and regulatory agencies in the EU member states to ensure the regulatory applications are approved in a timely manner
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel,
Partnering with their GRA counterpart in the LOC, the individual is the regulatory expert for assigned countries within the EU, ensuring that knowledge is transferred throughout the EU Regulatory team
Life sciences degree
Extensive experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency
Involvement in biologics, drug safety, pharmacovigilance and/or risk management
Significant knowledge of EU regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals
Considerable knowledge of the drug development process and the laws and regulations affecting pharmaceutical development in EU region
Prior experience and a track record of success in working with EMA & national agencies in the EU is essential
Minimum of 5 years experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency,

Regulatory Strategy Analyst Resume Examples & Samples

Enhancing and maintaining a central repository of information related to vendor management and sourcing for regulators across jurisdictions around the world
Evolving and delivering monthly reports on global regulators' activities related to vendor management and sourcing
Explaining regulatory requirements to key stakeholders as requested
Collaborating with colleagues across teams/divisions within UBS to deliver consistent responses to regulators on vendor management and sourcing topics
Coordinating ad-hoc requests, meetings, and presentations for regulators

EU Regulatory Strategy Product Specialist Resume Examples & Samples

Life Sciences degree
Significant experience in drug/biologics development within the EU pharmaceutical and biotechnology industry or Government Health Agency
Extensive knowledge of EU regulatory requirements
A deep understanding of the drug development process and laws and regulations affecting pharmaceutical development in EU region
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
Excellent interpersonal, communication, analytical, and organizational skills

Regulatory Strategy Lead Resume Examples & Samples

Provide transparency around global regulators' requirements related to vendor management and sourcing
Consolidate and coordinated opinions and interpretations of these requirements
Meet with UBS' global regulators on outsourcing matters, and respond to regulator requests
Advanced degree in Business, Law, Risk, or related disciplines
Experience leading a virtual team
Operational Risk Framework ("ORF 2") risk management and/or reporting
SORT reporting

Regulatory Strategy Lead Resume Examples & Samples

Designing and implementing a global strategy for monitoring, interpreting, and advising key stakeholders on regulatory guidance related to vendor management, with a particular focus on outsourcing
Benchmarking regulatory guidance across jurisdictions to UBS's Sourcing Framework and recommending changes
Reviewing and providing feedback to new and draft circulars
Collaborating with global colleagues in Legal, C&ORC, and Group Regulatory Relations to deliver consistent responses to regulators on vendor management and outsourcing topics
Line managing a colleague (Regulatory Strategy Analyst) responsible for
Enhancing and maintaining a central repository of regulatory communications
Evolving and delivering monthly reports on global regulators' activities

Regulatory Strategy & Engagement Resume Examples & Samples

2+ years of post Bachelors experience in Investment Banking/Financial Services or at a Regulatory Agency (e.g. Federal Reserve Bank of NY)
2+ years of demonstrated track record in regulatory projects
Familiarity with the CCAR process
Product/business knowledge covering various Markets/IBD businesses is a plus
Strong writing skills and ability to write appropriately for senior management and regulator audiences
Effective oral communication skills
Strong PC skills (Microsoft Suite including Excel, Word, PowerPoint and Visio, and Adobe Pro)
Strong interpersonal skills, including ability to persuade and/or negotiate to get desired outcome
Experience at working both independently and in a team-oriented, collaborative environment
Strong work ethic and commitment to the role and the team
Excellent communication, influencing, and relationship development skills, with a highly collaborative mind-set

Emission Regulatory Strategy Senior Manager Resume Examples & Samples

This position serves as both a subject matter expert and manager for highly sensitive Federal and State governmental emissions and environmental compliance topics including
Fleet average fuel economy and greenhouse gas regulations
Zero-emission electric vehicle mandates
Vehicle pollution requirements
Restricted material legislation
Advanced technology vehicle deployments
This role must produce, evaluate, and present key strategic regulatory options to VWGoA and factory leadership related to fleet emissions compliance with significant impact on current and future US Market operations, including possible financial penalties and other effects on vehicle certification
Frequent interaction and negotiation with governmental staff regarding sensitive VWGoA compliance options and projections is required. This includes regulatory reviews, discussions of future product plans/business decisions, and Group projections for future emission control technologies
This position must represent the interests of the Volkswagen Group on regulatory issues and serve as a "technical lobbyist/advocate" with regards to influencing and shaping future environmental requirements. This role is expected to interface on a regular basis with key governmental policy and technical staff, and must be prepared to negotiate for beneficial policy positions
In addition, this role is expected to support market assessments, government/industry/academic sponsored research, and other environmental policy research. Findings and positions are to be coordinated with VW AG, Audi AG, Porsche AG, and subsidiary development and certification departments to ensure environmental targets are adequately integrated into product development and research programs
This position will manage certain EEO regulatory staff, provide oversight to the MAT2 apprentice program, and support in managing the EEO Auburn Hills workshop
This position will coordinate the efforts of the regulatory team to ensure that relevant customers within the VW Group (both domestic and abroad) are abreast of the latest developments in emissions and environmental regulations which can directly impact future product strategy and legal compliance
The position will oversee team member analysis, presentation, and interpretation of regulations, including future compliance projections used throughout the VW Group for strategic planning
The Senior Manager must represent the VW group to important external customers such as government agencies, policy researchers, and trade/professional associations, including
10 years automotive engineering experience
5+ years automotive regulatory and government affairs experience
Bachelor’s Degree in Engineering or equivalent
Master’s Degree in Engineering or equivalent
Powertrain and whole vehicle design and development experience
Experience with emission and environmental regulations
Experience with fuels and alternative powertrains
Technical background in vehicles emissions and environmental topics including air quality, greenhouse gases, fuel economy technologies, etc
Expertise in working with US Federal and State regulatory databases and online services
Expertise in Federal and State rulemaking processes
Experience in legislative and other governmental processes
Communication skills – able to concisely communicate as a subject matter expert to general audiences, able to efficiently communicate ideas through interpersonal, presentation and written correspondence and across varied audiences
Presentation skills – providing concise information to both internal and external audiences
Experience in automotive development, technical engineering
Knowledge of advanced powertrain technologies including electrification
Experience with standards development organizations
Management of small teams including collaborative tools and processes
Policy analysis

Regulatory & Strategy Resume Examples & Samples

Strong knowledge foundation in some or all of financial products, accounting and p/l computation and regulatory capital concepts
Familiarity with risk management and risk measurement
Strong focus on internal controls and integrity of data
Ability to innovate & provide creative solutions
Dynamic individual who is able to use own initiative to identify what needs to be done, build strong relationships and be compelling and influential

Principal, Regulatory Strategy Resume Examples & Samples

Advanced Degree in Business, Economics, Finance, Mathematics, Engineering or related discipline
6 years+ of strong performance at relevant energy industry role (e.g. utility, regulator, consumer advocate, IPP, financial, research laboratory, consulting firm.)
Experience and track record of publicly advocating positions on contentious issues
Expertise in utility economics, regulation and ratemaking, and a desire to deepen expertise in these areas
Ability to translate theoretical and abstract economic concepts into practical quantitative findings that can influence policy and regulatory outcomes
Energy industry track record in completing comprehensive research and analysis projects, ideally linked to tangible, successful business outcomes
Ability to effectively communicate complex issues to a diverse set of audiences, internally and externally, in written, slide and oral form
Desire to creatively tackle complex and difficult regulatory issues and analytical questions with an appropriate utilization of theory and pragmatism
Passionate about utilizing her or his industry expertise to help realize SolarCity’s vision of distributed energy resources in every home
Detail-oriented, resourceful and able to manage shifting priorities
Ability to positively and effectively interact with internal and external customers
Regular, reliable and predictable performance required
Ability to work well with others in a collaborative team environment
Must be able to successfully pass a pre-employment criminal screen. Additional pre-employment driving and drug screens may be required based on job responsibilities
Experience working for a utility and/or at a utility regulator or consumer advocate
Direct experience testifying or supporting development of testimony or cross-examination in utility rate cases
Authorship of academic or industry publications
Proficiency or aptitude in common database and data analytics languages (e.g. R, Python, SQL)

Regulatory Strategy Resume Examples & Samples

Supporting thorough impact assessments of new banking regulation, assessing the potential economic and strategic impact of areas affected
Consolidating all the new business requirements emerging from new regulation, to identify common patterns within the portfolio and the potential strategic implications for the Bank
Developing new strategic options to adapt to new regulation when required
Coordinating periodic discussions with the business regulatory strategy
Ensuring a trust based partnership with the business divisions
Supporting executive decision making within the Regulatory affairs division, as well as the Management Board by providing accurate insights and analysis to take strategic decisions within the regulatory space
Supporting the development of an environment where people management and development is a top priority
Actively supporting Deutsche Bank’s strategy, plans and values, contributing to the achievement of a high performance culture
Acting as a role model for new employees, providing help and support to facilitate early integration and assimilation of their new environment
Bachelors degree or above, or the equivalent work experience or qualfications
Extensive experience working in investment banking and management consulting specifically in risk, regulatory and strategy arenas
Experience of credit risk
Strong financial product knowledge including over the counter derivatives, corporate loans, securitisations, securities lending, equities and fixed income & currencies
Expertise and experience in regulatory strategy and business planning
Experience of developing Basel II and III and risk weighted assets review and testing procedures
Experience of preparing board level presentations and papers
Excellent Microsoft Office Suite, SQL, Excel, PowerPoint and SharePoint skills
An excellent strategic thinker, with the ability to understand broad business issues and their strategic implications and to make sound business recommendations
Strong intellect, with the ability to deal with complex and ambiguous situations and challenge relevant content from others
An understanding of core banking issues relevant to banking and bank regulation including Internal Capital Adequacy Assessment Process (ICAAP)
Strong communications skills, with the ability to use both written and oral communication to gain organisational support and enthusiasm for initiatives
Strong interpersonal skills, a strong team player with high energy and "can do" attitude (high priority)
Fluent in English written and oral
Fluency in German (beneficial)

Director, Global Regulatory Strategy Immuno Resume Examples & Samples

Lead/Participate in Global Regulatory Teams (GRTs) Provide leadership to the global regulatory teams on critical project issues. Establish one regulatory voice and communicate same to key stakeholders. Develop registration strategy for a product. Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies. Develop strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
Prepare content for regulatory strategic documentation and Regulatory Project Reviews Align regulatory plans with commercial and development plans
Assure priority market and non-priority market regulatory issues are addressed in development plans. Assure CMC-components of overall global regulatory plan are robust
Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, etc
Review and approve key regulatory documents, including IB, IND, IMPDs, CTAs, RMP, Pediatric plans etc
Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience. Understanding of scientific content and complexities. A good knowledge of Oncology drug development is desired. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval
Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment
Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities
Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities
Experience utilizing leadership techniques to drive a team through the stages of team development
1603702

Global Regulatory Strategy Manager Resume Examples & Samples

Preferred: Solid scientific background (PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
Working knowledge of Regulatory Procedures (US or other) or in a specific Therapeutic Area (2-3 years)
Ability to rapidly adapt to different issues and projects at one time
Excellent communication
Comprehensive understanding of the Pharmaceutical Industry
Demonstrates a high-level of self-motivation and professional commitment
(In)direct management experience of people or major projects
1505641

Director, Clinical Regulatory Strategy Resume Examples & Samples

Serve as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project
Represent Global Regulatory Affairs (GRA) on cross-functional teams, including Project Development Teams
Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the GRA Management Team, Project Development Team and senior management, as relevant
Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate
Ensure alignment of regulatory strategy and plan on a continuous basis with the GRA Management Team and key cross-functional stakeholders
Provide overall regulatory functional leadership to the GRA sub-team, including participating in the skill development, coaching, and performance feedback for members of the regulatory sub-team, regardless of formal reporting relationship
May act as Regional Regulatory Program Lead in his or her base region, including leading all regional Health Authority interactions
Monitor changes in the regulatory environment with potential strategic impact, working closely with the Head of Regulatory Policy
May be responsible for line management and development of direct reports
Identify areas in need of improvement and lead the development and implementation of process improvements
Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
Capable of leading significant general projects for the function, including due diligence activities
Minimum of Bachelor's degree in relevant scientific discipline, higher degree desirable
A minimum 10 years Pharma experience, of which at least 10 years is in Regulatory Affairs
Experience with developing and implementing competitive regulatory strategies
Experience with line and matrix management
Demonstrated track record in securing product approvals and maintaining a complex portfolio
Experience dealing with broad range of stakeholders at all levels internal and external to the company
Demonstrated competence in employee management and development
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
Direct experience of leading regulatory authority meetings in different phases of drug development
Regulatory knowledge in a number of therapeutic areas

Global Regulatory Strategy Lead Immuno Resume Examples & Samples

Global Regulatory Strategy Lead (GRTL), Oncology will have leadership responsibility for global regulatory strategy for indications within the Hematology portfolio with opportunities to work on solid tumor across the matrix organization, depending on workload/available opportunities
Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Develop target labeling and co-lead the cross-functional labeling team. Ensure consistent positions are presented in responses to global HA queries
Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the GRT, develop global submission plans and Health Authority interaction plans
Provide input into the development of protocol synopses and protocols
Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines
Lead in Global Regulatory Teams (GRTs) Provide leadership to the global regulatory teams on critical project issues. Establish one regulatory voice and communicate same to key stakeholders. Develop registration strategy for a product. Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies. Develop strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
Represent GRS on Early Development, Full Development and World Wide Brand teams and to governance committees
Facilitate identification and internal agreement of optimal labeling
Provide strategic input on Target Product Profile, CCDS and country-specific labels Support effective interactions with HA globally Create an asset specific global HA interactions strategy, integrating regional/local objectives and strategies
Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
Drive the creation and execution of the global submission plan. Formulate integrated global submission plan for simultaneous filings and communicate rationale for deviation from simultaneous submissions
Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks
Ability to broadly represent GRS/GRA functions on project team in a matrix organization. Demonstrated ability to coordinate global activities
Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions)
1602359

Director of Regulatory Strategy Resume Examples & Samples

Oversees GDT regulatory leads within staff responsible ensuring global regulatory strategies are written and executed according to plan
Oversees multiple projects, generally has global oversight for compounds in a minimum of one disease area
Oversees and accountable for all relevant submissions and approvals within therapeutic area of responsibility for assigned programs
Oversees and accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local Takeda affiliates within therapeutic area of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy
In collaboration with global affairs, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy. Approves global regulatory strategies and authors for more complex regulatory strategies as needed; over see execution, generally delegates to staff
Supervises multiple direct reports. Manages, trains and provides oversight for staff day-to-day activities
Leads and manages meetings with regulatory authorities and agency meetings; or delegates and oversees direct reports; negotiates on behalf of project team as necessary
Lead interactions with health authorities, delegate to staff for general interactions
Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives
Lead regulatory reviewer in due diligence for licensing opportunities
Manages personnel within group to ensure coverage for project and therapy area(s) responsibilities; Elevates needs when necessary
Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
Presents to senior management
BSc. Advanced scientific related degree preferred; BA accepted based on experience
A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience
Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; global involvement also preferred
Experience in managing personnel required
Solid working knowledge of drug development process and regulatory requirements; knowledge of Americas, EU, Canada, ROW, and post-marketing a plus
Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy
Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Must be strong overall and able to train/develop staff 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 in working well with others, within global teams and communicating with senior leadership
Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff

Assoc Dir, Regulatory Strategy Resume Examples & Samples

Contributes to planning for the RCS function in assigned region/country
Contributes to the development of policies, goals, objectives, plans, and procedures for RCS functions under assigned span of control
Responsible for day to day management of their teams, and projects. Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods
Acts as a representative of the regulatory department with other departments
Supports business development, including generation of repeat business from existing clients, introduction of new clients, and proposal development

Director, Regulatory Strategy Resume Examples & Samples

Extensive clinical research experience and significant supervisory and/or project management experience
Experience or familiarity with document preparation and/or publishing systems preferred
Knowledge of procedures for reporting non-clinical and/or clinical study data
Extensive knowledge of FDA regulations and medical terminology

Senior Manager, Global Regulatory Strategy 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
Evaluates change proposals for regulatory impact and filing requirements
Fosters constructive working relationships when interacting with internal and/or external colleagues
Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
Exercises good judgement in elevating and communicating actual or potential issues to line management
Excellent written and oral communication skills required

Associate Director Global Regulatory Strategy Resume Examples & Samples

Function within a Therapeutic Area structure and have responsibility for planning and managing global and local regulatory drug activities for their assigned products in Oncology
Act as the primary interface between Bayer and the local Health Authority, e.g., FDA in the US, EMA in Europe
Organize and drives preparations for meetings and teleconferences with local HA officials
Represent a region in close cooperation with the GRS who is the GPT member or may represents GRA on assigned GPT
May participate in Global Project Team and working groups
Develop the local regulatory project goals from development through life cycle. Contribute to global regulatory strategy and project goals
Participate on and may lead a global regulatory team (GRT) and provides local regulatory input into the global development plan for assigned projects
Compile and submits IND and clinical trial applications (CTAs) to enable timely start of the clinical trials for the assigned development products with oversight from Lead GRS and supervisor
Work with Lead GRS, supervisor, and TA head to develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission
Collect, review and analyze competitor information, local and global Agency guidelines and precedence and provides advice to team with minimal supervision
Responsible for developing the global target labeling in close cooperation with GPT and RA Global Labeling
Provide guidance to other functions / staff to assure clinical trial programs are carried out in accordance with all regulations and applicable Bayer Standard Operating Procedures. Data from these trials should support product registration
Coordinate regulatory matters with license partners with the Lead GRS and TA supervisor
Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with 4 years in medical research activities of which 1+ years includes local/global regulatory experience in related therapeutic area. MS degree with 6 years industry experience of which 1+ years include local/global regulatory experience. BS degree with 8 years industry experience of which 3+ years of local/global regulatory experience
The incumbent must have in-depth knowledge of the region he /she will be responsible for (FDA / EMA regulations on Clinical trials applications and drug approval regulations). Familiarity with foreign regulations as well as of adverse drug event reporting requirements is also required
Excellent communication skills, verbal and written, are required
The ability to work within a global team framework and a multicultural environment is required
Strong analytical skills are necessary to interpret regulatory data and make critical decisions
The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure
In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection is also a plus
The working knowledge of medical procedures, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials is a plus
Oncology therapeutic experience is a plus
Strong management skills are a plus

EU Regulatory Strategy Product Specialist Resume Examples & Samples

Provides support for the EU regulatory strategy for assigned products (maintaining and extending Shire product registrations in European markets). Collaborates closely with all other key GRA stakeholders (including but not limited to, Global Regulatory Lead, labeling, CMC, regulatory operations, international regulatory team and regulatory staff in the EU Local Operating Companies) and key stakeholders outside GRA (including but not limited to CMC, non-clinical, clinical, pharmacovigilance and commercial) to ensure that all aspects of the regional strategy is coordinated and considered
Lead the cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
Acts as regulatory lead for all CTA applications conducted in the European region, coordinating with the assigned CRO and functional stakeholders to ensure the timely submission, approval and compliance of all CTA applications
Ensure appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency, SwissMedic and regulatory agencies in the EU member states to facilitate approval in a timely manner
Ensures that the approval is communicated to appropriate functions to allow implementation
Ensures all regulatory documentation is stored within Shire systems / databases in accordance with Shire standards
Communication and collaboration with the EU LOC team to ensure all parties are informed of all activities directly affecting their market
Minimum of 2 years experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency
Knowledge of EU regulatory requirements
Ability to challenge self, overcome barriers and deliver high quality solutions to the business
Understanding of the drug development process and laws and regulations affecting pharmaceutical development in EU region

Regulatory Strategy Product Specialist Resume Examples & Samples

The planning, coordination , organization and preparation of complete high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions
Ensuring regulatory compliance for all assigned responsibilites
Responsible for the implemention of regulatory strategies for the development and maintenance of assigned product or products
40%: Prepare, compile, review/qualilty control and process regulatory submissions including INDs, BLA, NDA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc
BA/B.S in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required

Associate Director Global Regulatory Strategy Resume Examples & Samples

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
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
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
Active participation in Agency/Industry groups/forums preferred

Regulatory Strategy Manager Resume Examples & Samples

Maintain a safe and healthful work environment by following established safe work practives and procedures; investigating and reporting identified safety concerns or situations
Implement standards contained in the Company “Code of Ethics & Business Conduct,” Company EEO practices, and DOE directives
Instill a strong, work-class safety ethic within the workforce by conducting all activities with the utmost attention to personal safety, operations safety, and environmental excellence
Develop, maintain and administer a comprehensive Environmental Management System (EMS) consistent with ISO 14001 and the DOE Integrated Safety Management System (ISMS) requirements
Assure that programs are established and maintained to provide direction to implement DOE directives and policies, state and federal laws and regulations, and Corporate environmental policy by
BA/BS in Engineering, Natural Science, or related environmental science discipline or recognized equivalent
12 years directly related professional experience in the field of specialization including 4 years in nuclear environment
A minimum of seven (7) years of management/supervisory experience

Risk-regulatory Strategy & Governance Adviser Resume Examples & Samples

Coordination of regulatory/internal audit strategies, review of materials for submissions and follow up of findings leading to their closure
Interaction with regional regulators and respond to their regular or ad-hoc information requests
Building professional relations with market risk managers at the regional and global levels to reduce regulatory risk
Monitor APAC regulatory landscape for new and amended regulation, assess impact on MRM and lead actions to close identified gaps
Carryout self assessment against existing regional regulation
Contribute to market risk policy development and review; conduct training on policy changes
Assist with other governance control activities like BCP

Senior / Regulatory Strategy Director Resume Examples & Samples

Responsible for the SDD-A business development strategy for China, Hong Kong, and Taiwan, and participates in and supports business development initiatives in the broader Asia Pacific region
Interacts closely with customers to understand their needs with respect to drug development
Leads discussions with customers on regulatory strategies pertaining to Asia Pacific by mapping out the geographic regulatory landscape, and identifying key regulatory issues critical for successful execution of the strategies
Together with customers develop sound and implementable regulatory strategies for Asia Pacific countries
Stays abreast on significant regulatory developments in the greater China area and Asia Pacific in general, and enhances and further develops SDD-A regulatory intelligence
Supports global strategic consulting projects by providing local regulatory input
Provides regulatory thought leadership in forums like conferences, seminars and industry discussion groups
May act as a global contact and/or lead for a specific customer
May take a proactive role in developing long standing relationships with preferred Quintiles customers, and may take a leadership role in bid defense strategy and planning, as appropriate
Significant exposure to the regulatory environment in China, Hong Kong, and Taiwan specifically and the broader Asia Pacific region in general
Advanced knowledge and ability to understand implications of regulatory developments
In-depth knowledge of strategic regulatory aspects of clinical drug development including market authorization, orphan drug status and post approval requirements in the greater China area
An acute awareness of changes in the regulatory environment and how these changes implicate on the Asia Pacific and global regulatory environment
Hands on experience with support for and reporting on (pre-clinical, CMC, and clinical) Gap Analysis projects, Due Diligence projects, drafting of Clinical Development Plans, and Regulatory Authority consultations in the greater China area
Native Chinese speaker with excellent verbal and written English communication skills, with the ability to collaborate with regulatory and other functional teams across cultural and geographic boundaries
The ability to project a professional demeanor and be a respected and credible partner for customers, external thought-leaders and Health Authority agencies
Strong leadership skills in being able to lead regulatory discussions in a virtual global project team and to synthesize the final regulatory strategy
Strategic thinker, with the patience to overcome complexity and the ability to challenge the status quo
At least a Bachelor’s degree in Pharmacy or equivalent
At least 5 years of regulatory affairs experience gained working in a CRO
At least 5-10 years of Regulatory Affairs experience supporting clinical product development projects in the biopharmaceutical or biotech industry
Or combination of education, training and experience

Senior Rates & Regulatory Strategy Analyst Resume Examples & Samples

Rate case / Rider filings & Support
Cost of service, rate and pricing, modeling and financial analysis work
Regulatory filings, compliance activities and shared service rate work
Regulatory strategy analysis, reporting and support
Resolving strategic company or jurisdictional initiatives
Four year degree in Business, Accounting/Finance, Mathematics, Computer Science or related field and 4+ years of prior equivalent work related experience OR 8+ years of experience in lieu of degree
Master’s degree in Business, Finance, Accounting, Economics, Engineering, Statistics, or Mathematics
Experience working for a regulated utility
Ability to operate and exercise judgment autonomously with limited supervision
Attention to detail, commitment to accuracy, and initiative to investigate questions and data irregularities
Ability to assimilate large amounts of data and draw conclusions
Ability to verbally explain complex calculations and concepts to others
Ability to foster positive working relationships with colleagues and third parties
Ability to lead projects that require coordination across multiple departments
Utility rate case support experience
Demonstrated experience with SAS and/or database applications
Ability to develop and use complex spreadsheets utilizing advanced techniques such as array formulas, pivot tables, and macros

Global Head of Regulatory Strategy Resume Examples & Samples

Leads the Global Regulatory Strategy) Team, ensuring that the GRL Global Regulatory Lead) resource provides high quality, strategic advice and is seen as a valued strategic partner across the organization and builds effective relationships with major regulatory agencies
Ensures delivery of major new product filings and that lifecycle registration and compliance commitments are met
Determines clear priorities for the GRL Team and communicates those to the business so that expectations are appropriately managed
Owns a portfolio of regulatory delivery projects (up to 40% of available time)
Participates as a full and active member of the Regulatory Affairs Leadership Team, other key function working parties and key decision making bodies within GE Healthcare (e.g. portfolio Committee and Phase Review Discipline) and acts as delegate for Global Head of Regulatory Affairs as appropriate
Ensures effective strategies are in place for attraction, retention and succession planning for the GRS Team
Implementation and management of effective resource allocation processes within the GRS team and deployment of external support to meet business demands
Supports and encourages a collaborative, open and team based cultures across the global function
Engenders close and effective working relationships with regional Regulatory and RISM (Regulatory Information and Submission Management) colleagues and actively resolves areas of conflicts or sub optimal operation
Ensures that function systems and supporting processes are adequate for effective GRS Team operation and that an ongoing process improvement mind set is instilled within the team
Bachelor of Science degree in a related discipline
10-15 years of experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
Significant experience of Leadership of global regulatory strategy and global regulatory teams
Experience of regulatory project management and regulatory agency interactions
Experience of management of regulatory projects in global regulatory organizations
Experience of working globally and across different cultures
Third party management and vendor selection experience (desirable)
Master’s Degree in a related discipline
Ability to lead and inspire
Persuasive, influential, decisive and tenacious
Ability to communicate effectively, both written and verbally, in English
Engenders team work
Ability to juggle and prioritize multiple competing priorities and complete tasks on-time
Ability to assign clear priorities

International Regulatory Strategy Product Lead Resume Examples & Samples

Potential to mentor junior members of the regulatory team as required by the business
Leads cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, ODD, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
Communication and collaboration with relevant stakeholders including GRLs and International LOCs to ensure they are fully informed of all activities with the regions
Minimum of 5 years experience in drug/biologics development either within the pharmaceutical and biotechnology industry or Government Health Agency,
Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in International region. Prior experience and a track record of success in working with International partners (LOC’s/distributors)

Director, Global Regulatory Strategy Resume Examples & Samples

8+ years’ experience in drug development in the Pharma, biotech or CRO industry
6+ years’ experience developing global regulatory strategies for early and late stage development programs
CNS clinical trial expertise

Global Banking & Markets Regulatory Compliance Americas Head of Regulatory Strategy Resume Examples & Samples

Understanding of advanced Compliance risk frameworks in major financial services firms
Candidate would need excellent interpersonal, communication and influencing skills and confidence to deal with senior and executive level staff to defend guidance, sell the benefits of Compliance risk management and challenge their operating environment
Working across all levels of the organization to understand cross-functional linkages and interdependencies, as well as the implications of Compliance risk at both a strategic level and at the business unit level
Ability to form effective relationships and achieve influence at the most senior level in the organization
Investigative and regulatory supervisory skills to drive deep-dive reviews of specific business activities and conduct
Ambition to enhance compliance knowledge and skills in a rapidly changing and dynamic markets environment
Willingness to embrace advisory compliance role challenges
Ability to lead and motivate compliance officers with a reporting line into the role
Good report writing skills
Sound judgment
Graduate degree preferred (JD or MBA)
Knowledge of jurisdiction rules in relation to securities, derivatives and banking rules and regulations

Senior Rates & Regulatory Strategy Analyst Resume Examples & Samples

Rate case/ Rider filings & Support
Four year degree in Business, Accounting/Finance, Mathematics, or related field and 4+ years of prior equivalent work related experience OR 8+ years of experience in lieu of degree
Utility work experience
Regulatory accounting experience
Rate case support experience
MBA or CPA
Demonstrated effective analytical and problem-solving skills
Four year degree in Business, Accounting/Finance, Mathematics, Engineering or related field
Attention to detail, including ability to recognize irregularities in data, and commitment to high level of accuracy
Proficient skills in Microsoft products such as Excel, Word, and PowerPoint
Good time management skills – ability to meet deadlines and work with little supervision
Self-motivated; Ability to work independently and in a team environment; demonstrated initiative within current team
Ability to verbally explain calculations and filings to others
Ability to influence others, gain support of proposals and recommendations
Experience with financial applications (i.e., PeopleSoft FMIS, Power Plant, etc.) and query tool (Business Objects)
Exposure and familiarity with the FERC Uniform System of Accounts

Director, Regulatory Strategy 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 and assure the progress of projects by providing direction, solutions and feedback to the teams
Lead interactions with regulatory agencies for your projects and products
Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including CMC, nonclinical, and clinical activities
Support the company’s commercial products
Interact with Regulatory Affairs personnel at partner companies
Establish and meet timelines for regulatory submissions
Maintain awareness and communicate with team members regarding changing regulatory requirements

Regulatory & Strategy Officer Based Resume Examples & Samples

Have a Master degree in business management/ Master of Laws/ Master in Economics & Finance
Have knowledge of the regulatory developments affecting the financial industry
Have a first experience within the banking / insurance / fund industry is an asset
Ideally have a two to three years experience in audit
Demonstrate ability to work autonomously as well as part of a team
Have excellent analytical skills; eager to learn
Have excellent interpersonal and communication skills
Are fluent in French and English, German would be considered as an asset

International Regulatory Strategy Product Lead Resume Examples & Samples

Provide international regulatory strategy support for assigned products (maintaining and extending Shire product registrations in International markets) under the direction of Team Lead-International Regulatory Strategy
Support (or Lead where required) cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, ODD, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
Acts as International regulatory contact for all applications conducted in the International region, coordinating with the assigned CRO (where appropriate) and functional stakeholders to ensure the timely submission, approval and compliance of all applications
Remains knowledgeable about current regulations and guidance
Good understanding of drug/biologics development within pharmaceutical and biotechnology industry or Government Health Agency
Understanding of the drug development process and laws and regulations affecting pharmaceutical development in International region

ED, Enterprise Regulatory Strategy & Policy Resume Examples & Samples

Develop strategies and influence functional areas to deliver coordinated, quality regulatory activity
Institute a community of practice among regulatory affairs professionals to create a culture of transparency and generate accountability
Effectively lead and direct the coordination of regulatory activities across Kaiser Permanente. This includes collaborating with both regional and national regulatory functions as well as business, legal, policy and advocacy areas
Establish a common source of information about key regulatory activity across the Program
Lead the expansion of effective relationships and develop a community of practice among all departments performing regulatory activities across KP
Improve lines of communication across existing units responsible for regulatory implementation, advocacy, analysis and compliance
Identify and implement best practices in regulatory affairs across the Program and the industry
Manage the identification, assessment and communication of emerging regulatory issues for consideration and decision making by senior leadership
Represent Regulatory Affairs management across the Program and externally
Minimum eight (8) years of experience managing a team leading regulatory affairs and policy making within health care or health insurance setting and have substantial experience working with federal and state insurance regulators
Minimum five (5) years of experience managing regulatory and public policy functions both inside and outside of government
Master’s in business or health related area or Juris Doctor (JD) preferred

Director Regulatory Strategy Resume Examples & Samples

Work with Covance functional areas and clients to assess and/or develop the highest quality advice on regulatory strategy, supporting non-clinical development to first in human studies for client products by maintaining awareness of current regulatory legislation, guidance’s, precedence and current thinking within Agencies
Interact with Global Regulatory Strategy and Regional Regulatory Strategy personnel to be sure final regulatory positions are well vetted and aligned across multiple geographies and Covance business units
Evaluates the impact of clinical/regulatory changes on client’s projects as well as Covance business practices
Ensure effective communication with immediate management
Build effective relationships with Regulatory Authorities and promote a positive image for Covance
Work in an autonomous manner providing scientific and regulatory strategic consulting (written and oral) to support new product development
Develop and promote Covance’s capability to provide a specialized regulatory and scientific service by supporting existing projects/clients and by identifying and pursuing opportunities to expand regulatory activities
Ensure that Regulatory Agency interactions that are scientific or strategic in nature are incorporated into project timelines
Provide leadership and strategic direction for non-clinical regulatory strategy activities across all Covance business units
Collaborate closely and build effective relationships with Regulatory Submissions and Medical/regulatory Writing staff
Prepare time and cost estimates for regulatory strategy activities
Provide regulatory strategy expertise and support to the business development group in presentations to Pharma/biotech customers when requested

Senior Manager, Global Regulatory Strategy Resume Examples & Samples

Work closely with the Regulatory Strategist in identifying opportunity-related regulatory considerations, and defining the correspondent necessary material to support client deliverables
Perform reviews, summarize and compare/contrast relevant regulatory guidances
Establish productive working relationship with all Global Regulatory Affairs personnel, (Regulatory Submissions staff, Medical and Regulatory Writing, Regulatory Project Management)
Collaborate closely with internal Covance project teams in responding to client RFPs
Work effectively with Business Development Directors (Sales) in a support role as needed, including guiding customers towards strengths and solutions
Collaborate with the Global Regulatory Affairs group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise
Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by EMA, FDA, Health Canada, and elsewhere
Build effective working relationships with employees across Covance
Experience in medical writing, discovery research, preclinical pharmacology, toxicology, or clinical research preferred
Knowledge of regulatory guidance in multiple regions and industry best practices for drug development
Experience in participating in teams through IND, CTA development, assisting in addressing agency questions to support the start up of clinical trials
Ability to manage multiple assignments and varied tasks with enthusiasm and prioritize workload with attention to detail
The ability to develop effective multi-cultural relationships
Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential

Regulatory Strategy Analyst Resume Examples & Samples

Provide transparency around global regulators' requirements related to sourcing and vendor management
Anticipate how existing and emerging regulatory requirements impact UBS's Sourcing Framework
Meet with our key global regulators on a consistent basis

Associate Director Global Regulatory Strategy Immuno Resume Examples & Samples

Global Regulatory Strategy Lead (GRTL) will have leadership responsibility for developing and implementing the global regulatory strategy to support the development and delivery of diagnostic tests to enhance the value of our pharmaceutical products across therapeutic areas
Provide regulatory support and guidance to Diagnostic Partners, Global Regulatory Leads (GRTLs), development teams and/or project drug/diagnostic subteams on the regulatory strategy and execution of the integrated drug / diagnostic development plan
Ensure global regulatory plans support a precision medicine approach (ie integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies
Support the preparation of health authority documents and governance presentations containing precision medicine plans
Propose innovative approaches to resolve complex regulatory issues and increase speed to patients
Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs and PMAs
Experience in successfully leading teams
Experience working with external partners
Demonstrated matrix leadership skills and the ability to work effectively across multiple disciplines internal and external to the organization
Strong understanding of the drug development process and global regulatory requirements for drugs in development
Understanding of science in oncology and impact on the regulatory process
Prior experience with SRDs, IDEs, and PMAs and experience developing companion diagnostics is highly desired
Advanced technical degree, e.g., PhD, MD, PharmD, M.S. is preferred

Senior Director Global Regulatory Strategy Resume Examples & Samples

Achieve assigned regulatory project goals, milestones and labeling, from development through life cycle
Provide regulatory advice on clinical trial design based on competitor intelligence and guidelines and Agency meeting strategy for evaluation of major clinical trials
Design and assess regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory plan), ensuring active feed-back from and robust agreements/approvals with/by regional and functional RCT members, Bayer internal functions involved in the development and life cycle process as well as external regulatory advisors in academia
Develop the initial target labeling (and competitor labeling) in close cooperation with GRA Global Labeling
Own and voice the Regulatory Risk assessment in alignment with GRA management
Communicate and manage these regulatory measures in all major all major global markets via the Regulatory Core Team members and/or local Bayer regulatory departments
Communicate with the regional health authority in the assigned region for his/her specific projects, keeping track of all communications and requests in appropriate contact reporting databases and ensuring appropriate internal and external communication of all Regulatory relevant issues
Lead the development of the Briefing document for the Health authority meeting
Lead a global regulatory team (GRT) and coordinate world-wide regulatory input into the global development plan for assigned projects
Ensure that the target labeling, and Regulatory Strategy Plans address the needs of the specifically assigned region (Global/US/EU)
Maintain the Bayer global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters and monitor the company meets all post marketing commitments in close co-operation with the functions
Coordinate the activities of a small group of Global Regulatory Managers assigned to major development projects
Bachelor’s degree with 14 years industry experience of which 5 years include global regulatory experience in related therapeutic area or 5 years of local regulatory experience in a highly drug-regulated country or
Master’s degree with 12 years industry experience of which 5 years include global regulatory experience in related therapeutic area or 5 years of local regulatory experience in a highly drug-regulated country
Working knowledge of foreign regulations as well as of adverse drug event reporting requirement
Broad experience and communications skills as the incumbent must be able to knowledgeably discuss and effectively deal with, as well as provide training, on issues such as product safety and drug regulation compliance with Bayer medical staff, clinical investigators, marketing staff, quality assurance staff, Bayer medical and coordination staff, FDA, EMEA and responsible individuals in other pharmaceutical companies
Managerial ability to direct and develop staff and to guide and implement international clinical compliance strategies and training
Thorough knowledge of company policies and procedures in drug development and maintenance is essential
Demonstrated originality in problem solving as applied to drug Regulatory issues and have skills and experience dealing with drug Health Authorities
Strong analytical regulatory skills to interpret regulatory data and make critical decisions
Skilled in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working with many cultures and time zones. In many cases competing objectives will have to be harmonized and reconciled to achieve the overall objectives
Managerial know-how involves the ability to lead a dynamic, energized and creative work team. The incumbent must provide the team with clear vision, direction, and purpose
Understanding of different cultures and knowledge of Human Resource practices
Oncology experience is preferred. We will consider candidates with experience in other therapeutic areas

VP, Commercial Regulatory Strategy Resume Examples & Samples

Serving as the lead for the PRB to ensure purposeful cross functional discussions in a solutions-orientated and time-sensitive manner, and fostering cross functional collaboration
Work closely with the business owner to optimize the quality of the materials and accelerate their review and approval
Provide unique, novel, and innovative solutions to enhance the business efforts in a compliant manner while exploring and optimizing digital strategies
Lead the development of best practices, respective processes, and internal and external training to ensure consistent, accurate and quality review of PRB submissions
Provide strategic input on pre-commercialization materials, input into labeling, and assessing all aspects of the impact to promotion to ensure coordinated efforts and strategy for anticipated launches
Provide timely updates on new FDA guidances, enforcement trends, and other environmental triggers that may impact promotion and the business
Provide strategic input on special projects as assigned by the President & COO
15 years' related experience required
Previous experience in PAH space strongly preferred
Advanced degree required; PharmD preferred

Director Global Regulatory Strategy Resume Examples & Samples

Make decisions on all key development questions as member of the project team (as all decisions impact the Regulatory dossier and approval processes, i.e. preclinical and clinical study and program designs, licensing, etc.)
Represent worldwide Regulatory Affairs on assigned Global Project Teams or represent a region in close cooperation with the Global Regulatory Strategist (GRS) who is the Global Project Team (GPT) member
Ensure submission and approval of clinical trial applications to enable timely start of the clinical trials for the assigned development products
Design and assess regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory plan), ensuring active feed-back from and robust agreements/approvals with/by regional and functional RCT members, company internal functions involved in the development and life cycle process as well as external regulatory advisors in academia
Identify overall Regulatory direction for appropriate development plans and optimized approval chances of the agreed target labeling
Keep abreast of changes in the Regulatory environment for the project to anticipate necessary adaptations
Contribute to strong Issue Management as a member of an appropriate sub-team
Ensure early identification of major Regulatory Issues relating to clinical, technical, strategic or operational information impacting successful Clinical Trial Authorizations, and/or Marketing Authorizations Applications/approvals for assigned projects
Develop the Health Authority meeting plan for validation of development programs at different stages in close co-operation with GPT and RCT in alignment with RA management (GRASC , ERMM as appropriate)
Lead or facilitate the Bayer Global Review for assigned project submissions to finalize and approve Clinical trial (i.e. IND) and Marketing Application submissions dossiers (i.e. NDA) (not applicable for liaison role)
Maintain the company global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters and monitor the company meets all post marketing commitments in close co-operation with the functions
Evaluate new strategic concepts and license opportunities for the product
Review promotional material on global level (Interface to promotional integration team)

Director of Global Regulatory Strategy Resume Examples & Samples

Design and assess regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory plan), ensuring active feed-back from and robust agreements/approvals with/by regional and functional RCT members, client internal functions involved in the development and life cycle process as well as external regulatory advisors in academia
Identify corrective regulatory measures and immediate actions required in case of deviations jeopardizing global PD product goals
Communicate and manage these regulatory measures in all major all major global markets via the Regulatory Core Team members and/or local client regulatory departments
Achieve assigned global Regulatory Milestones and owner of the Regulatory risk assessment for these Milestones
Represent Global Regulatory Affairs at major Board of Health (BoH) meetings for assigned projects (GRS who is GPT member as well as Regional GRS)
Create and/or manage a strong network for assigned projects with the health authority in the assigned region, and other key regulatory influencers and stakeholders, that facilitates the incorporation of regulatory intelligence and influence into the regulatory project strategy with the goal to increase overall approval chances
Build and maintain an overview on available documentation for assigned projects via a database or equivalent tracking tool in close cooperation with Global Submission, which includes all regulatory documents needed to support and maintain Clinical Trial Authorizations (INDs, CTX, etc.) and/or Marketing Authorizations (NDAs, MAAs,NDSs, etc.) in line with current Regulatory standards and guidelines
Lead or facilitate the client Global Review for assigned project submissions to finalize and approve Clinical trial (i.e. IND) and Marketing Application submissions dossiers (i.e. NDA) (not applicable for liaison role)
Maintain the client global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters and monitor the company meets all post marketing commitments in close co-operation with the functions
Coordinate all Regulatory matters with license partner in Joint Development Committees
Advanced technical degree Ph.D., MD, DVM or Pharm D is preferred in life sciences with 10 years industry experience of which 5 years include global regulatory experience in related therapeutic area or 5 years local regulatory line management experience in a highly drug-regulated country or with 3 of these years’ experience in a country with greater responsibility(versus highly regulated country)
In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection
Working knowledge of medical procedures, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials
Oncology experience is preferred; will consider candidates with experience in other therapeutic areas
Broad experience and communications skills as the incumbent must be able to knowledgeably discuss and effectively deal with, as well as provide training, on issues such as product safety and drug regulation compliance with client medical staff, clinical investigators, marketing staff, quality assurance staff, client medical and coordination staff, FDA, EMEA and responsible individuals in other pharmaceutical companies
Sensitivity to the diverse cultures comprising the global Regulatory community
Scientific and technical expertise, including the ability to develop robust regulatory plans covering all phases of drug development
Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure
Strong management skills for the leader of a global regulatory team operating in a matrix environment and coordination of a small group of Global Regulatory Managers Strategy Leadership
Motivational, interpersonal and issue resolution skills
Skilled in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working with many cultures and time zones; in many cases competing objectives will have to be harmonized and reconciled to achieve the overall objectives
Managerial know-how involves the ability to lead a dynamic energized and creative work team
The incumbent must provide the team with clear vision, direction, and purpose

Associate Director Global Regulatory Strategy Oncology Resume Examples & Samples

Act as the primary interface between Bayer and the local Health Authority (HA), e.g., FDA in the US, EMA in Europe. This position will support Oncology
Represent a region in close cooperation with the Global Regulatory Strategist (GRS) who is the global project team (GPT) member or may represent Global Regulatory Affairs (GRA) on assigned GPT
Develop the local regulatory project goals from development through life cycle
Compile and submits IND and clinical trial applications (CTA’s) in order to enable timely start of the clinical trials for the assigned development products with oversight from Lead GRS and supervisor
Works with Lead GRS, supervisor, and TA head to develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission
Collect, review and analyze competitor information, local and global agency guidelines and precedence and provide advice to team with minimal supervision
Be responsible for developing the global target labeling in close cooperation with GPT and GRA Global Labeling
Provide guidance to other functions/staff to assure clinical trial programs are carried out in accordance with all regulations and applicable Bayer Standard Operating Procedures. Data from these trials should support product registration
Provide regulatory risk assessment for project on a local basis and possibly global level and is able to support that input based on regulatory precedence and product characteristics
Co-ordinate regulatory matters with license partners with the Lead GRS and TA supervisor
Advanced technical degree (Ph.D., D.V.M. or Pharm.D.). in life sciences with four (4) years in medical research activities of which one to three (1-3) years includes local/global regulatory experience in related therapeutic area or M.S. degree with six (6) years industry experience of which one to three (1-3) years includes local/global regulatory experience or B.S. degree with eight (8) years industry experience of which three to five (3-5) years includes local/global regulatory experience
In-depth knowledge of the region he/she will be responsible for (EMA/ FDA regulations on Clinical trials applications and drug approval regulations)
Must be familiar with foreign regulations as well as of adverse drug event reporting requirements
Excellent communication skills, verbal and written
The ability to work within a global team framework and a multi- cultural environment
Must focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure
Oncology experience

Risk Head of Regulatory Strategy & Governance Resume Examples & Samples

Coordinate regulatory and internal audit strategies, review of materials for submissions and follow up of findings leading to their closure
Interact with regional regulators and respond to their regular or ad-hoc information requests
Build professional relationships with market risk managers at the regional and global levels to reduce regulatory risk
Carryout self-assessment against existing regional regulation

Associate Director Global Regulatory Strategy Resume Examples & Samples

Act as the primary interface between Bayer and the local Health Authority (HA), e.g., FDA in the US, EMA in Europe
Organize and drive preparations for meetings and teleconferences with local HA officials
Represent a region in close cooperation with the Global Regulatory Strategists (GRS) who is the Global Project Team (GPT) member or may represent Global Regulatory Affairs (GRA) on assigned GPT
Participate in Global Project Team and working groups
Contribute to global regulatory strategy and project goals
Participate on and may lead a Global Regulatory Team (GRT) and provide local regulatory input into the global development plan for assigned projects
Compile and submit Investigational New Drugs (IND) and Clinical Trial Applications (CTAs) to enable timely start of the clinical trials for the assigned development products with oversight from Lead GRS and supervisor
Work with Lead GRS, supervisor, and Talent Acquisition (TA) head to develop submission materials for local HA, guide the review process, check for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission
Collect, review and analyze competitor information, local and global Agency guidelines and precedence and provide advice to team with minimal supervision
Develop the global target labeling in close cooperation with GPT and GRA Global Labeling
Provide guidance to other functions / staff to assure clinical trial programs are carried out in accordance with all regulations and applicable Bayer Standard Operating Procedures (data from these trials should support product registration)
Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with four (4) years in medical research activities of which one (1) to three (3) years includes local/global regulatory experience in related therapeutic area, M.S. degree with six (6) years industry experience of which one (1) to three (3) years include local/global regulatory experience, or B.S. degree with eight (8) years industry experience of which three (3) to five (5) years of local/global regulatory experience
Must have in-depth knowledge of the region he/she will be responsible for (EMA/ FDA regulations on Clinical trials applications and drug approval regulations)
Familiarity with foreign regulations as well as of adverse drug event reporting requirements
Must have working knowledge of medical procedures, drug therapy, statistical concepts and the collection and computerization
In-depth knowledge of reporting of data collected in clinical trials
Strong management skills
The ability to work within a global team framework and a multicultural environment
Must be able to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure

CIB F&BM Reg W Regulatory Strategy Controller Resume Examples & Samples

Work on designated projects focused on regulatory strategy implementation and partner with identified resources for issue resolution
Become a subject matter expert in this area to partner with businesses to develop a better understanding of the issues applicable to Reg W transactions
Prepare decks and analysis for monthly CIB Reg W Monthly Forums
Help identify gaps in current reporting process and participate in the implementation of new controls and strategic technology solutions
Work with line of business Reporting Contacts to ensure that they are in compliance with the rules and regulations related to the submissions of Reg W covered transactions
Identify issues for follow-up and resolution with Line of Business Managers, Financial Controllers, Product Controllers and/or Reporting Contacts
Bachelors degree in Accounting or Finance, or equivalent experience
2-3 years financial services experience
Highly proficient in Microsoft Excel and Powerpoint, ideally also with strong Microsoft SharePoint and InfoForm skills
Ability to execute tasks with aggressive time frames and multi-task in an ever changing environment
Take ownership of issues, processes and projects, and multi-task
Work independently and effectively while managing time and completing priorities
Detail oriented and self motivated
Ability to effectively interact with various levels of management and global employees

Senior Director, Regulatory Strategy Resume Examples & Samples

Lead, develop and implement regulatory strategy in order to meet corporate goals and objectives
Provide regulatory oversight and guidance to project teams on compliance matters, FDA and other competent authority requirements, clinical study design issues and on timing, logistics and operational recommendations for product development
Work proactively in a cross-functional organization to partner with various other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical development plan
Lead the planning, preparation and delivery of submissions throughout the product's life cycle, including briefing documents, INDs, CTAs and annual reports
Lead the planning, strategy, content and execution of NDA filing and approval
Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
Prepare the team and lead negotiations with FDA and other health agencies
Ensure that the Regulatory Department interfaces with key functional groups (Development, Manufacturing, Sales, Marketing, and Quality Assurance) to drive company-wide initiatives
Provide regulatory due diligence as required
Supervise and mentor direct reports who will be managing other programs
Bachelor’s degree in life sciences with 15 years industry experience of which 10 years include regulatory experience
Successful submission, approval, and post-approval management of an NDA/MAA/NDS in multiple ICH regions
Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions
Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
Demonstrated Strategic Thinking – Capable of strategic thinking and proposing innovative solutions to regulatory problems
Strong influencing and negotiation skills
Advanced technical degree MSc or Ph.D. is preferred in life sciences
Regulatory Affairs Certification (RAC)

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