Director, RA Global Regulatory Strategy
BioSpace2 days ago
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OnsiteFull-timeSenior
Summary
AbbVie is seeking a Director, RA Global Regulatory Strategy to join their team in Florham Park, NJ. The role involves developing and implementing global strategies to secure and maintain market approval for products in the assigned therapeutic area.
About the Role
As the Director Regulatory Affairs Global Regulatory Lead (GRL II), you will lead the Global Regulatory Product Team (GRPT) and be responsible for ensuring compliance with global regulatory requirements. You will develop creative global strategies, manage projects, and serve as the primary regulatory interface with cross-functional teams. Your role will also involve risk assessment, regulatory policy development, and influencing regulatory guidance.
About You
Required:
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- 7+ years regulatory experience, including drug development experience in the US&C region.
- Proven 5+ years in a strategic leadership role with strong project management skills.
- Strong communication and proactive negotiation skills.
Preferred:
- Relevant advanced degree is preferred. Certification a plus.
- 10+ years experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan.
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k).
- Eligibility to participate in short-term incentive programs.
BioSpace
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Florham Park, NJ