Director, RA Global Regulatory Strategy
AbbVie
August 08, 2026
Remote friendly (Florham Park, NJ)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, develops and implements global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Expands therapeutic area knowledge and ensures strategic messaging/content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates/mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development phases and throughout the product life cycle, including post-approval. Develops/implements acceleration strategies and manages projects and documentation for regulatory strategies.
Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations to meet business objectives.
- Lead cross-functional/regulatory teams to ensure strategic messaging in dossiers and responses to agency requests.
- Accountable for corporate goals; driver of regulatory policy/strategy for assigned products.
- Lead preparation/maintenance of global regulatory product strategies, including risk assessment/mitigation; communicate plans to stakeholders.
- Independently act under direction; expand TA knowledge; coach/mentor GRPT members; may manage direct reports.
- Influence regulations/guidance by analyzing legislation/regulations/guidance and providing organization-wide analysis.
- Ensure regulatory record-keeping compliance; may develop RA department policies/procedures.
- Align regulatory strategies with senior management; present assessments/recommendations to executive management; inform AST/cross-functional leadership of issues/labeling outcomes/risks and mitigations.
- Make decisions on work processes/operational plans/schedules to meet program objectives.
- Follow budget allocations; track resourcing; chair/sponsor key initiatives and present outcomes.
Qualifications:
- Required education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred education: Relevant advanced degree; certification a plus.
- Required experience: 7+ years regulatory experience; drug development experience in US&C region; 5+ years in strategic leadership with strong project management; complex matrix experience influencing cross-functional teams; interfaces with major government regulatory bodies; strong communication and proactive negotiation; experience developing/implementing successful global regulatory strategies.
- Preferred experience: 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development foundation with business acumen.
Benefits (if explicitly stated): Comprehensive package including paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations to meet business objectives.
- Lead cross-functional/regulatory teams to ensure strategic messaging in dossiers and responses to agency requests.
- Accountable for corporate goals; driver of regulatory policy/strategy for assigned products.
- Lead preparation/maintenance of global regulatory product strategies, including risk assessment/mitigation; communicate plans to stakeholders.
- Independently act under direction; expand TA knowledge; coach/mentor GRPT members; may manage direct reports.
- Influence regulations/guidance by analyzing legislation/regulations/guidance and providing organization-wide analysis.
- Ensure regulatory record-keeping compliance; may develop RA department policies/procedures.
- Align regulatory strategies with senior management; present assessments/recommendations to executive management; inform AST/cross-functional leadership of issues/labeling outcomes/risks and mitigations.
- Make decisions on work processes/operational plans/schedules to meet program objectives.
- Follow budget allocations; track resourcing; chair/sponsor key initiatives and present outcomes.
Qualifications:
- Required education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred education: Relevant advanced degree; certification a plus.
- Required experience: 7+ years regulatory experience; drug development experience in US&C region; 5+ years in strategic leadership with strong project management; complex matrix experience influencing cross-functional teams; interfaces with major government regulatory bodies; strong communication and proactive negotiation; experience developing/implementing successful global regulatory strategies.
- Preferred experience: 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development foundation with business acumen.
Benefits (if explicitly stated): Comprehensive package including paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.