Associate Director Regulatory Affairs
2 weeks ago
Job Description: Title: Associate Director, Regulatory Affairs (Contract) Location: Remote or Hybrid Contract Duration: 6-12 months (with potential extension) About the Role: We are seeking an experienced Associate Director of Regulatory Affairs to join our team on a contract basis. This role will support regulatory strategy and execution across development programs, ensuring compliance with global health authority requirements. The ideal candidate is a proactive problem-solver with strong leadership skills and handson experience in regulatory submissions. Key Responsibilities: Develop and implement regulatory strategies for assigned programs in alignment with business objectives. Lead preparation, review, and submission of regulatory documents (INDs, NDAs, MAAs, amendments, briefing packages). Serve as primary liaison with global health authorities and manage regulatory interactions. Provide guidance to crossfunctional teams on regulatory requirements and timelines. Monitor changes in regulations and assess impact on development programs. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. 8+ years of regulatory affairs experience in the pharmaceutical or biotech industry. Proven track record in leading regulatory submissions and interactions with FDA and/or EMA. Strong understanding of drug development process and applicable regulations. Excellent communication, organizational, and leadership skills. Why Join Us? Opportunity to work on innovative programs in a dynamic environment. Flexible remote or hybrid work options. Competitive contract terms and potential for extension. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr
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Associate Director Regulatory Affairs
7 days ago
Boston, MA, United States Real Staffing Full timeJob ** Associate Director, Regulatory Affairs (Contract) Remote or Hybrid Contract * 6-12 months (with potential extension) About the * We are seeking an experienced Associate Director of Regulatory Affairs to join our team on a contract basis. This role will support regulatory strategy and execution across development programs, ensuring compliance with...
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Associate Director, Regulatory Affairs
3 days ago
Boston, MA, United States Foundation Medicine Full timeThe Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for Foundation Medicine products. Foundation Medicines products include diagnostic assays that provide...
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Associate Director, Regulatory Affairs
2 days ago
Boston, MA, United States Foundation Medicine Full timeThe Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for Foundation Medicine products. Foundation Medicines products include diagnostic assays that provide...
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Associate Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Foundation Medicine Full timeThe Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for Foundation Medicine products. Foundation Medicines products include diagnostic assays that provide...
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Associate Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Foundation Medicine Full timeAbout the Job The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for Foundation Medicine products. Foundation Medicines products include diagnostic...
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Associate Director, CMC Regulatory Affairs
2 weeks ago
Boston, MA, United States Alkermes Full timeAssociate Director, CMC Regulatory Affairs Join to apply for the Associate Director, CMC Regulatory Affairs role at Alkermes Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by...
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Boston, MA, United States Takeda Full timeAssociate Director, Global Regulatory Affairs, Advertising and Promotion Join Takeda as an Associate Director, Global Regulatory Affairs, Advertising and Promotion . This role involves managing programs/products as the internal expert on US and international codes, guidance, and industry standards related to prescription medicine promotion. Key...
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Remote Associate Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Real Staffing Full timeA leading staffing organization is seeking an experienced Associate Director of Regulatory Affairs to support regulatory strategy on a contract basis. The role offers flexible remote or hybrid options and involves leading regulatory submissions and maintaining compliance with global health authorities. Candidates should have over 8 years of regulatory...
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Associate Director, CMC Regulatory Affairs
3 weeks ago
Boston, United States Alkermes Full timeAssociate Director, CMC Regulatory Affairs Join to apply for the Associate Director, CMC Regulatory Affairs role at Alkermes Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by...
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Boston, United States Dechra Full timeVacancies Associate Director/Director, Biologics CMC Regulatory Affairs Job Introduction This is a US remote role, with a preference for candidates based in the Boston area. Invetx, a division of Dechra , is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on...
