Senior Director, Global Regulatory Strategy Lead – FDA Regulatory SME

AbbVie

Senior Director responsible for global regulatory strategy and FDA compliance at AbbVie. Overseeing product development and providing expert regulatory guidance across therapeutic areas.

Posted 7/29/2026full-timeRemote • Illinois • 🇺🇸 United StatesSenior💰 $206,500 - $393,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in FDA regulations and product development strategies, with a proven track record in developing and implementing global regulatory strategies to secure market approval. Strong leadership and communication skills are essential for managing complex projects and interfacing with regulatory agencies.

Highest-signal resume keywords

FDA Regulatory ExpertiseGlobal Regulatory Strategy DevelopmentLeadership in Matrixed EnvironmentsRegulatory Documentation ReviewNegotiation and Strategic Thinking

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory StrategyProduct Development OversightRegulatory ComplianceFDA InteractionClinical FoundationPortfolio ManagementRegulatory Documentation ReviewMarket Approval ProcessesExperience in Multiple MOAs

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationNegotiation SkillsBusiness AcumenAbility to Work Under Pressure

Certifications & Qualifications

Regulatory CertificationAdvanced Degree (PharmD, PhD, MS)

Industry Keywords

Therapeutic AreasFDA RegulationsRegulatory DossiersPost-Approval DevelopmentGovernment Regulatory Agencies

About the role

Key responsibilities & impact

Responsible for 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
Develops and implements global regulatory strategies to secure and maintain market approval
Ensures strategic messaging in US regulatory dossiers
Reviews regulatory documentation for compounds through all phases of development, including post-approval
Provides consultation and direction on compliance with US regulatory requirements
Recommends acceleration strategies
Provides training and advice to RA colleagues on FDA regulatory policy interpretation
Leverages deep FDA regulatory expertise to assess programs across therapeutic areas
Responsible for oversight of complex product development and project management
Communicates to the regulatory team and cross-functionally to carry out objectives established by executive management

Requirements

What you’ll need

Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
minimum 15 years Regulatory, R&D, or equivalent industry-related experience
10+ years of experience at the FDA with increasing responsibilities
Leadership experience working in a complex and matrixed environment
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

Benefits

Comp & perks

paid time off (vacation, holidays, sick)
medical/dental/vision insurance
401(k) to eligible employees
participate in our long-term incentive programs