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Regulatory Affairs Director
2 months ago
AbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic regulatory guidance and support to our global development teams.
Key Responsibilities- Develop and implement regulatory strategic and tactical planning (RSTP) for assigned on-market products or those in development.
- 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.
- 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.
- 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).
- Strong understanding of regulatory requirements and guidelines for drug development and approval.
- Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
- Ability to analyze complex data and develop strategic recommendations.
- Strong organizational and project management skills, with ability to prioritize multiple tasks and meet deadlines.
- Proficiency in regulatory software and systems, such as electronic submissions and document management.
