Director, RA Global Regulatory Strategy
AbbVie
5 months ago
Remote friendly (Florham Park, NJ)
United States
Corporate Functions
Director Regulatory Affairs Global Regulatory Lead (GRL II) – Global Regulatory Strategy
Responsibilities:
- Develop and implement global 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).
- Ensure strategic messaging and content of global regulatory dossiers; lead cross-functional/regulatory teams to prepare dossier content and responses to agency requests.
- Proactively anticipate and mitigate regulatory risks; ensure compliance with global regulatory requirements.
- Manage compounds across all phases of development and throughout product life cycle (including post-approval).
- 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 by analyzing legislation/regulatory guidance and providing organizational analysis.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments and recommendations; inform stakeholders of issues, labeling outcomes, approvals, risks, and mitigations.
- Make decisions on work processes/operational plans/schedules to achieve senior management program objectives.
- Monitor budget allocations and resourcing; chair or sponsor key regulatory initiatives and present outcomes.
Qualifications:
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Advanced degree; certification is a plus.
- Required: 7+ years regulatory experience; drug development experience in the US & Canada region.
- Required: 5+ years in a strategic leadership role with strong project management.
- Required: Experience in complex/matrix environments; strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience, including experience as lead regulatory product strategist in two or more major regions (e.g., EU, Japan) in addition to the US.
- Note: Higher education may compensate for years of experience.
Benefits (as stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.
Responsibilities:
- Develop and implement global 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).
- Ensure strategic messaging and content of global regulatory dossiers; lead cross-functional/regulatory teams to prepare dossier content and responses to agency requests.
- Proactively anticipate and mitigate regulatory risks; ensure compliance with global regulatory requirements.
- Manage compounds across all phases of development and throughout product life cycle (including post-approval).
- 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 by analyzing legislation/regulatory guidance and providing organizational analysis.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments and recommendations; inform stakeholders of issues, labeling outcomes, approvals, risks, and mitigations.
- Make decisions on work processes/operational plans/schedules to achieve senior management program objectives.
- Monitor budget allocations and resourcing; chair or sponsor key regulatory initiatives and present outcomes.
Qualifications:
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Advanced degree; certification is a plus.
- Required: 7+ years regulatory experience; drug development experience in the US & Canada region.
- Required: 5+ years in a strategic leadership role with strong project management.
- Required: Experience in complex/matrix environments; strong communication and proactive negotiation skills; experience developing and implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience, including experience as lead regulatory product strategist in two or more major regions (e.g., EU, Japan) in addition to the US.
- Note: Higher education may compensate for years of experience.
Benefits (as stated):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.