Senior Manager, Global Regulatory Affairs Strategy, US

1 month ago

Chicago, Illinois, United States AbbVie Full time
Job Summary

AbbVie is seeking a highly skilled Senior Manager, Global Regulatory Affairs Strategy, to join our team in the US. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support for global development, ensuring compliance with regulatory requirements, and driving the development and implementation of regulatory strategic and tactical planning.

Key Responsibilities
  • Provide regulatory strategy and support for global development, including identifying and gathering data to support filings, responses to inquiries, and registration maintenance.
  • Support teams and efforts around major filing activities and Regulatory Health Authority (RHA) interactions and meetings, attending and providing regulatory support to other departments, project teams, and committees.
  • Organize regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions.
  • Develop and implement regulatory strategic and tactical planning (RSTP) for assigned on-market products or those products in development.
  • Assist Regulatory Staff by identifying and gathering data to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant regulatory HA requirements.
  • Responsible for products within a Therapeutic Area and support the Global Regulatory Lead (GRL) and Therapeutic Area Head with the development and execution of the regulatory strategy.
  • Serve as HA liaison with FDA for routine communications in support of filings, including complete and timely responses during application review.
  • Write regulatory documents, such as meeting requests and/or briefing book activities, and lead draft review meetings.
  • Advise internal cross-functional teams who may contribute to regulated communication on Regulatory/FDA issues, including Public Affairs, Clinical Development, Legal, and others, such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics.
  • Present pertinent regulatory information to appropriate cross-functional areas.
  • Responsible for operating in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and Quality Dossier Program (QDP).
Qualifications
  • Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology) or industry-related.
  • Required Experience: 6 years Regulatory, R&D, or Industry-related experience.
  • Skillset needed:
    • Experience interfacing with government regulatory agencies.
    • Experience organizing regulatory submissions to health authorities (HAs); identifying and gathering data to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant regulatory HA requirements; and interpreting FDA/EMA regulations, guidelines, policy statements, etc. for drug therapeutics.
    • Demonstrates excellent communication and negotiation skills. Proven skill at implementing successful US and Canada regulatory strategies.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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