Job DescriptionThe Senior Director, Global Regulatory Strategy Lead and FDA Regulatory SME is responsible for oversight of complex product development within and across Therapeutic Areas and provides FDA-specific subject matter expertise at the intersection of FDA regulations, guidances, policy, and product development strategy, while supporting global regulatory strategy. Develops and implements global regulatory strategies to secure and maintain market approval. The Senior Director FDA Regulatory SME ensures strategic messaging in US regulatory dossiers, provides consultation and direction on compliance with US regulatory requirements. Reviews regulatory documentation for compounds through all phases of development, including post-approval, and recommends acceleration strategies, all while demonstrating a deep understanding of FDA requirements, drug development, and strong leadership capabilities. As the FDA Regulatory SME, this individual provides training and advice to RA colleagues on FDA regulatory policy interpretation and the implications of FDA requirements within the scope of expertise. This role reports directly to the VP, Global Regulatory Strategy.
- Leverages deep FDA regulatory expertise to assess programs across therapeutic areas and leads a team of global regulatory professionals for strategy on development and marketed products. Responsible for oversight of complex product development and project management. Accountable for ensuring that corporate goals are met.
- Manages the content of global, US and Canadian regulatory dossiers. Provides oversight and approval for content of global regulatory dossiers. Serves as a key internal leader and driver of FDA regulatory policy interpretation and strategy, with implications for global, US, and Canadian programs
- Leads preparation of global regulatory product strategies for assigned products, with a primary emphasis on FDA regulatory requirements and US approval pathways. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
- Provides executive management with informed regulatory strategies and risk assessments grounded in FDA regulatory expertise. Provides mentoring and coaching to other regulatory and cross-functional personnel. May have direct reports.
- May initiate, participate in, or lead RA or cross-functional initiatives. Trains and advises internal personnel on FDA regulatory policy interpretation, FDA guidance implications, and the impact of FDA requirements within scope of expertise
- Works broadly across TAs for assigned products and influences the development of FDA regulations and guidance. Advises management on the effect of current, newly finalized, or proposed FDA laws, regulations, guidelines, standards, and advisory committee recommendations on assigned products. Analyzes and interprets competitive data including labeling based on information available (EPARs, SBAs, clintrials.gov)
- Provides expert FDA subject matter assessment on disease state insights, vision, and direction to differentiate assets; delivers regulatory intelligence on the FDA regulatory environment and provides recommendations to accelerate and optimize product development. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department, and if applicable, ensures direct reports follow requirements.
- Proactively informs regulatory management of issues and provides an assessment of impact on the global, US, and Canadian programs, with particular attention to FDA regulatory implications and the specific area of FDA expertise. Provides informed regulatory opinion based on FDA experience and expertise.
- Works with GRPT to develop and communicate goals that are in alignment with business goals. Communicates to the regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management. Makes decisions regarding work processes or operational plans and schedules in order to achieve program objectives established by senior management.
- Participates in and takes leadership roles in professional associations, industry and trade groups as appropriate for assigned projects. Represents GRS externally as a thought leader on advanced FDA regulatory and SME issues to shape FDA guidances and acts as a culture change champion, as needed, based on initiatives across GRS. Represents Regulatory on AbbVie governance and review committees upon request.
Qualifications- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 15 years Regulatory, R&D, or equivalent industry-related experience.
- Proven experience in a leadership role with strong management skills, demonstrated executive presence.
- 10+ years of experience at the FDA with increasing responsibilities across therapeutic programs.
Leadership experience working in a complex and matrixed environment with multiple stakeholders and on cross-functional teams - Experience bringing pharmaceutical products through development review and approval. Broad experience contributing to enterprise management of a portfolio of products
- Experience developing and implementing successful global regulatory strategies. Experience interfacing with FDA and other government regulatory agencies.
- Strong verbal and written communicator with strong negotiation skills and strategic thinking. Strong business acumen and the ability to work under pressure.
- Extensive experience interfacing with multiple regional government regulatory agencies preferred.
- Clinical foundation preferred with strong business acumen. Experience in multiple MOAs
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
