Director, RA Global Regulatory Strategy
AbbVie
6 hours ago
Remote friendly (Florham Park, NJ)
United States
$177,000 - $336,000 USD yearly
Corporate Functions
Director, Regulatory Affairs Global Regulatory Strategy
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval in obesity/metabolic.
- Lead the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST); serve as primary regulatory interface with AST and supporting teams.
- Ensure strategic messaging/content in global regulatory dossiers and responses to agency requests.
- Proactively anticipate, assess, and mitigate regulatory risks; ensure compliance with global regulatory requirements.
- Manage obesity/metabolic compounds through all development phases, including post-approval lifecycle.
- Lead global regulatory product strategy preparation, including risk assessment and mitigation strategy development; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations/guidance.
- Ensure regulatory record keeping policies are followed; develop/implement RA policies and procedures as needed.
- Align strategies with senior management; provide regulatory assessments/recommendations to executive management.
- Make decisions on work processes/operational plans to achieve senior management program objectives; sponsor/chair key initiatives and present outcomes.
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience; drug development experience in US&C region.
- Proven 5+ years strategic leadership with strong project management.
- Experience in complex matrix environments; influence cross-functional teams.
- Experience interfacing with major government regulatory bodies.
- Strong communication and proactive negotiation skills; experience developing/implementing global regulatory strategies.
- Preferred: Relevant advanced degree; 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k) eligibility; short-term and long-term incentive program eligibility.
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval in obesity/metabolic.
- Lead the Global Regulatory Product Team (GRPT) and Labeling Regulatory Strategy Team (LRST); serve as primary regulatory interface with AST and supporting teams.
- Ensure strategic messaging/content in global regulatory dossiers and responses to agency requests.
- Proactively anticipate, assess, and mitigate regulatory risks; ensure compliance with global regulatory requirements.
- Manage obesity/metabolic compounds through all development phases, including post-approval lifecycle.
- Lead global regulatory product strategy preparation, including risk assessment and mitigation strategy development; communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations/guidance.
- Ensure regulatory record keeping policies are followed; develop/implement RA policies and procedures as needed.
- Align strategies with senior management; provide regulatory assessments/recommendations to executive management.
- Make decisions on work processes/operational plans to achieve senior management program objectives; sponsor/chair key initiatives and present outcomes.
Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- 7+ years regulatory experience; drug development experience in US&C region.
- Proven 5+ years strategic leadership with strong project management.
- Experience in complex matrix environments; influence cross-functional teams.
- Experience interfacing with major government regulatory bodies.
- Strong communication and proactive negotiation skills; experience developing/implementing global regulatory strategies.
- Preferred: Relevant advanced degree; 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k) eligibility; short-term and long-term incentive program eligibility.