Director, RA Global Regulatory Strategy
AbbVie
August 14, 2026
Remote friendly (Florham Park, NJ)
United States
$182,000 - $346,000 USD yearly
Operations
Job Description:
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global strategies to secure and maintain market approval for products 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. Anticipates/mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development phases and the product life cycle. Develops and implements acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities:
- Interface with LRST and AST to lead/support cross-functional objectives; lead GRPT to develop global regulatory strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in dossiers and responses to agency requests.
- Drive regulatory policy and strategy; accountable for corporate goal attainment.
- Lead preparation/maintenance of global regulatory product strategies, including risk assessment/mitigation and stakeholder communication.
- Independently operate under GRS Sr GRL/TA Head direction; expand TA knowledge and coach/mentor GRPT members.
- Analyze legislation/regulations/guidance and provide organizational recommendations with worldwide accountability.
- Maintain regulatory record-keeping and develop RA policies/procedures as needed.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of issues, labeling outcomes, approvals, and risks/mitigations; represent RA in joint governance.
- Manage work processes/schedules; support professional associations and industry leadership as appropriate.
- Follow budget allocations; chair/sponsor key GRS initiatives and present outcomes to RA LT.
Qualifications:
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years strategic leadership with strong project management; matrix/cross-functional influence; communication and proactive negotiation; successful global regulatory strategy development.
- Preferred: Relevant advanced degree; certification a plus; 10+ years regulatory experience, including lead regulatory product strategist in 2+ major regions (e.g., EU/Japan); strong global drug development foundation and business acumen.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive programs.
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global strategies to secure and maintain market approval for products 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. Anticipates/mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development phases and the product life cycle. Develops and implements acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities:
- Interface with LRST and AST to lead/support cross-functional objectives; lead GRPT to develop global regulatory strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in dossiers and responses to agency requests.
- Drive regulatory policy and strategy; accountable for corporate goal attainment.
- Lead preparation/maintenance of global regulatory product strategies, including risk assessment/mitigation and stakeholder communication.
- Independently operate under GRS Sr GRL/TA Head direction; expand TA knowledge and coach/mentor GRPT members.
- Analyze legislation/regulations/guidance and provide organizational recommendations with worldwide accountability.
- Maintain regulatory record-keeping and develop RA policies/procedures as needed.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of issues, labeling outcomes, approvals, and risks/mitigations; represent RA in joint governance.
- Manage work processes/schedules; support professional associations and industry leadership as appropriate.
- Follow budget allocations; chair/sponsor key GRS initiatives and present outcomes to RA LT.
Qualifications:
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years strategic leadership with strong project management; matrix/cross-functional influence; communication and proactive negotiation; successful global regulatory strategy development.
- Preferred: Relevant advanced degree; certification a plus; 10+ years regulatory experience, including lead regulatory product strategist in 2+ major regions (e.g., EU/Japan); strong global drug development foundation and business acumen.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive programs.