Director, RA Global Regulatory Strategy
AbbVie
August 08, 2026
Remote friendly (North Chicago, IL)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies.
Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional stakeholders to ensure strategic messaging in global regulatory dossiers and responses to agency requests.
- Lead preparation and maintenance of risk assessment and mitigation strategy; communicate plans to stakeholders.
- Analyze legislation/regulations/guidance and provide organization-wide analysis with worldwide accountability.
- Ensure alignment of global regulatory strategies with senior management; present assessments and recommendations; inform stakeholders of issues/labeling outcomes/risks and mitigations.
- Manage regulatory record keeping; develop/implement RA policies and procedures.
- Coordinate resourcing/budgets; chair or sponsor key initiatives and present outcomes.
Qualifications:
Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related; 7+ years regulatory experience including US&C drug development; 5+ years in strategic leadership with strong project management; matrix experience; experience interfacing with major government regulators; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
Preferred: Relevant advanced degree; certification a plus; 10+ years regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan); strong global drug development foundation and business acumen.
Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional stakeholders to ensure strategic messaging in global regulatory dossiers and responses to agency requests.
- Lead preparation and maintenance of risk assessment and mitigation strategy; communicate plans to stakeholders.
- Analyze legislation/regulations/guidance and provide organization-wide analysis with worldwide accountability.
- Ensure alignment of global regulatory strategies with senior management; present assessments and recommendations; inform stakeholders of issues/labeling outcomes/risks and mitigations.
- Manage regulatory record keeping; develop/implement RA policies and procedures.
- Coordinate resourcing/budgets; chair or sponsor key initiatives and present outcomes.
Qualifications:
Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related; 7+ years regulatory experience including US&C drug development; 5+ years in strategic leadership with strong project management; matrix experience; experience interfacing with major government regulators; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
Preferred: Relevant advanced degree; certification a plus; 10+ years regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan); strong global drug development foundation and business acumen.