Director, RA Global Regulatory Strategy
AbbVie
June 29, 2026
Remote friendly (Florham Park, NJ)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
Job Description
- 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 Labeling Regulatory Strategy Team (LRST).
- Ensure strategic messaging and content of global regulatory dossiers and responses to agency requests.
- Serve as primary regulatory interface with AST and supporting teams; anticipate and mitigate regulatory risks.
- Manage compounds through all development phases, including post-approval lifecycle.
- Develop and implement acceleration strategies; manage regulatory strategy projects and documentation.
Responsibilities
- Lead GRPT to create global strategies aligned with regulations and business objectives; seek expert input when needed.
- Lead cross-functional regulatory stakeholders to ensure clear strategic messaging in dossiers and agency responses.
- Drive regulatory policy and strategy; lead preparation and maintenance of risk assessment/mitigation plans.
- Independently act under direction; expand TA knowledge and coach/mentor; may manage direct reports.
- Analyze regulations/guidance and provide worldwide accountability for assigned products.
- Ensure regulatory recordkeeping compliance; may develop RA department policies.
- Align strategies with senior management; present recommendations and impacts; represent regulatory position in Joint Governance.
- Make work/process decisions; influence via associations; manage resourcing and sponsor key initiatives.
Qualifications
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: relevant advanced degree; certification a plus.
- Required: 7+ years regulatory experience; drug development experience in US & C region; 5+ years in strategic leadership with strong project management; complex matrix environment experience; interface with major government regulators.
- Required: strong communication and proactive negotiation; develop/implement global regulatory strategies.
- Preferred: 10+ years in pharmaceutical regulatory; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) besides US; strong global drug development foundation and business acumen.
Benefits (as stated)
- Paid time off; medical/dental/vision insurance; 401(k); eligibility for long-term incentive programs.
- 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 Labeling Regulatory Strategy Team (LRST).
- Ensure strategic messaging and content of global regulatory dossiers and responses to agency requests.
- Serve as primary regulatory interface with AST and supporting teams; anticipate and mitigate regulatory risks.
- Manage compounds through all development phases, including post-approval lifecycle.
- Develop and implement acceleration strategies; manage regulatory strategy projects and documentation.
Responsibilities
- Lead GRPT to create global strategies aligned with regulations and business objectives; seek expert input when needed.
- Lead cross-functional regulatory stakeholders to ensure clear strategic messaging in dossiers and agency responses.
- Drive regulatory policy and strategy; lead preparation and maintenance of risk assessment/mitigation plans.
- Independently act under direction; expand TA knowledge and coach/mentor; may manage direct reports.
- Analyze regulations/guidance and provide worldwide accountability for assigned products.
- Ensure regulatory recordkeeping compliance; may develop RA department policies.
- Align strategies with senior management; present recommendations and impacts; represent regulatory position in Joint Governance.
- Make work/process decisions; influence via associations; manage resourcing and sponsor key initiatives.
Qualifications
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: relevant advanced degree; certification a plus.
- Required: 7+ years regulatory experience; drug development experience in US & C region; 5+ years in strategic leadership with strong project management; complex matrix environment experience; interface with major government regulators.
- Required: strong communication and proactive negotiation; develop/implement global regulatory strategies.
- Preferred: 10+ years in pharmaceutical regulatory; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) besides US; strong global drug development foundation and business acumen.
Benefits (as stated)
- Paid time off; medical/dental/vision insurance; 401(k); eligibility for long-term incentive programs.