Senior Director, Global Regulatory Strategy Lead & FDA Regulatory SME

AbbVie•North Chicago, IL

3d•$206,500 - $393,000

About The Position

The 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.

Requirements

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.

Nice To Haves

Extensive experience interfacing with multiple regional government regulatory agencies preferred.
Clinical foundation preferred with strong business acumen.
Experience in multiple MOAs

Responsibilities

Oversight of complex product development within and across Therapeutic Areas
Provides FDA-specific subject matter expertise at the intersection of FDA regulations, guidances, policy, and product development strategy
Supports global regulatory strategy
Develops and implements global regulatory strategies to secure and maintain market approval
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
Recommends acceleration strategies
Provides training and advice to RA colleagues on FDA regulatory policy interpretation and the implications of FDA requirements
Leverages deep FDA regulatory expertise to assess programs across therapeutic areas
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 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
May develop and implement policies and procedures within the RA department
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
Acts as a culture change champion, as needed, based on initiatives across GRS
Represents Regulatory on AbbVie governance and review committees upon request