Director, RA Global Regulatory Strategy
AbbVie
9 hours ago
Remote friendly (Florham Park, NJ)
United States
Corporate Functions
The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) in an assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses, serves as a regulatory interface with the AST and supporting teams, ensures compliance with global regulatory requirements, manages compounds through development and product life cycle, and develops and implements acceleration strategies.
Responsibilities:
- Interface with LRST and AST to implement cross-functional objectives; lead GRPT development of global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and agency responses.
- Drive regulatory policy and strategy for assigned products; lead preparation and maintenance of global regulatory product strategies.
- Lead development and maintenance of risk assessment and mitigation strategies and communicate plans to stakeholders.
- Analyze legislation/regulations/guidance and provide organizational analysis with worldwide accountability for assigned products.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments/recommendations to executive management.
- Make decisions on work processes/operational plans and schedules to meet program objectives; manage resourcing within budget.
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: 5+ years regulatory experience; 3+ years in strategic leadership role with strong project management; experience in matrix environments; experience interfacing with government regulatory agencies.
- Skills: Strong communication and proactive negotiation; business acumen; able to work under pressure.
- Preferred Experience: 7+ years pharmaceutical regulatory activities (ideally in 2+ regions/countries); experience developing/implementing global regulatory strategies; drug development and strong clinical foundation preferred (higher education may compensate).
Benefits (if applicable to role): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; short-term incentive program eligibility.
Responsibilities:
- Interface with LRST and AST to implement cross-functional objectives; lead GRPT development of global strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in global regulatory dossiers and agency responses.
- Drive regulatory policy and strategy for assigned products; lead preparation and maintenance of global regulatory product strategies.
- Lead development and maintenance of risk assessment and mitigation strategies and communicate plans to stakeholders.
- Analyze legislation/regulations/guidance and provide organizational analysis with worldwide accountability for assigned products.
- Ensure alignment of global regulatory strategies with senior management; present regulatory assessments/recommendations to executive management.
- Make decisions on work processes/operational plans and schedules to meet program objectives; manage resourcing within budget.
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: 5+ years regulatory experience; 3+ years in strategic leadership role with strong project management; experience in matrix environments; experience interfacing with government regulatory agencies.
- Skills: Strong communication and proactive negotiation; business acumen; able to work under pressure.
- Preferred Experience: 7+ years pharmaceutical regulatory activities (ideally in 2+ regions/countries); experience developing/implementing global regulatory strategies; drug development and strong clinical foundation preferred (higher education may compensate).
Benefits (if applicable to role): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; short-term incentive program eligibility.