Director, RA Global Regulatory Strategy
BioSpacea day ago
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OnsiteFull-timeSenior
Summary
AbbVie is seeking a Director, RA Global Regulatory Strategy to join their team in North Chicago, IL. 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, you will lead the Global Regulatory Product Team and develop creative global strategies in line with applicable regulations. You will ensure compliance with global regulatory requirements, manage compounds through all phases of development, and proactively mitigate regulatory risks. The role requires collaboration with cross-functional teams and the ability to influence regulatory policy and strategy for assigned products.
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.
- Experience developing and implementing successful global regulatory strategies.
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.
- Strong global drug development foundation with business acumen.
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligibility to participate in short-term incentive programs.
BioSpace
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North Chicago, IL