Director, RA Global Regulatory Strategy
AbbVie
4 months ago
Remote friendly (North Chicago, IL)
United States
Corporate Functions
Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); may lead the Labeling Regulatory Strategy Team (LRST).
- Serve as the primary regulatory interface with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure strategic messaging and content of global regulatory dossiers and responses to regulatory agency requests.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and risk mitigation plans; communicate plans to relevant stakeholders.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments and recommendations to executive management.
- Influences development of regulations and guidance through analysis of legislation, regulations, and guidance.
- Manage regulatory record keeping; develop and implement RA departmental policies/procedures as needed.
- Lead project decisions, work processes, and operational plans/schedules; manage projects and regulatory strategy documentation.
- Manage resourcing and budget allocations; chair or sponsor key GRS 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 the US & C region; 5+ years in strategic leadership with strong project management; experience in complex matrix environments and influencing cross-functional teams; strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
- Preferred Experience: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU, Japan); strong global drug development foundation and business acumen.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) eligibility; eligible for long-term incentive programs.
- Develop and implement global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); may lead the Labeling Regulatory Strategy Team (LRST).
- Serve as the primary regulatory interface with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure strategic messaging and content of global regulatory dossiers and responses to regulatory agency requests.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment and risk mitigation plans; communicate plans to relevant stakeholders.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments and recommendations to executive management.
- Influences development of regulations and guidance through analysis of legislation, regulations, and guidance.
- Manage regulatory record keeping; develop and implement RA departmental policies/procedures as needed.
- Lead project decisions, work processes, and operational plans/schedules; manage projects and regulatory strategy documentation.
- Manage resourcing and budget allocations; chair or sponsor key GRS 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 the US & C region; 5+ years in strategic leadership with strong project management; experience in complex matrix environments and influencing cross-functional teams; strong communication and proactive negotiation skills; experience developing and implementing successful global regulatory strategies.
- Preferred Experience: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in two or more major regions in addition to the US (e.g., EU, Japan); strong global drug development foundation and business acumen.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) eligibility; eligible for long-term incentive programs.