Manager, Labeling Regulatory Affairs Strategic Labeling
AbbVie2 days ago
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OnsiteFull-timeSenior
Summary
AbbVie is seeking a Manager, Labeling Regulatory Affairs Strategic Labeling to join their team in North Chicago, IL. The role involves developing and maintaining US/EU package inserts and Company Core Data Sheets while ensuring global consistency of labeling.
About the Role
As a Manager in Labeling Regulatory Affairs, you will lead teams on labeling decisions, educate others on new labeling regulations, review and assess data for accuracy, drive strategic labeling processes, maintain accurate labeling change history, and collaborate with cross-functional teams to resolve labeling issues. You will also work with safety groups on safety-related labeling changes and provide labeling support to Asset Development Teams.
About You
Required:
- Bachelor’s degree in Pharmacy, Biology, Chemistry, pharmacology or related subject.
- 6 years of experience in Pharmaceutical, regulatory, R&D or industry related area.
Preferred:
- 3 years in pharmaceutical or regulatory experience.
- Minimum 3 years’ experience in clinical or pharmaceutical settings.
- Cross-divisional team experience and strong problem-solving skills.
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.
AbbVie
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need. Learn more about us at www.abbvie.com and review our community guidelines at https://www.abbvie.com/social-media-community-guidelines.html.
North Chicago, IL