Director, RA Global Regulatory Strategy
AbbVie
August 30, 2026
Remote friendly (Florham Park, NJ)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for assigned therapeutic area product(s).
- Lead the Global Regulatory Product Team (GRPT); may lead the Labeling Regulatory Strategy Team (LRST).
- Expand TA knowledge; ensure strategic messaging and content of global regulatory dossiers; lead/ensure responses to agency requests.
- Serve as primary regulatory interface with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure compliance with global regulatory requirements; manage compounds through development through post-approval lifecycle.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and mitigation plans; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations/guidance with worldwide accountability.
- Follow and develop regulatory recordkeeping policies/procedures; ensure team compliance.
- Provide regulatory assessments/recommendations to executive management; inform cross-functional leadership of issues, labeling outcomes, risks and mitigations.
- Manage work processes/operational plans and schedules; chair/sponsor key regulatory initiatives and present outcomes.
Qualifications:
Required:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience, including drug development experience in the US&C region.
- 5+ years in strategic leadership role with strong project management.
- Experience in complex matrix environment; communication and proactive negotiation skills.
Preferred:
- Relevant advanced degree; certification a plus.
- 10+ years in pharmaceutical regulatory activities, including lead regulatory product strategist in 2+ major regions (e.g., EU, Japan) plus US; global drug development foundation with business acumen.
Benefits (if stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for assigned therapeutic area product(s).
- Lead the Global Regulatory Product Team (GRPT); may lead the Labeling Regulatory Strategy Team (LRST).
- Expand TA knowledge; ensure strategic messaging and content of global regulatory dossiers; lead/ensure responses to agency requests.
- Serve as primary regulatory interface with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure compliance with global regulatory requirements; manage compounds through development through post-approval lifecycle.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and mitigation plans; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations/guidance with worldwide accountability.
- Follow and develop regulatory recordkeeping policies/procedures; ensure team compliance.
- Provide regulatory assessments/recommendations to executive management; inform cross-functional leadership of issues, labeling outcomes, risks and mitigations.
- Manage work processes/operational plans and schedules; chair/sponsor key regulatory initiatives and present outcomes.
Qualifications:
Required:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience, including drug development experience in the US&C region.
- 5+ years in strategic leadership role with strong project management.
- Experience in complex matrix environment; communication and proactive negotiation skills.
Preferred:
- Relevant advanced degree; certification a plus.
- 10+ years in pharmaceutical regulatory activities, including lead regulatory product strategist in 2+ major regions (e.g., EU, Japan) plus US; global drug development foundation with business acumen.
Benefits (if stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.