EPM Scientific
Senior Manager, Regulatory Affairs
EPM Scientific - Brockton, Massachusetts, us, 02301
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Are you the right applicant for this opportunity Find out by reading through the role overview below. Regulatory Affairs - Recruitment Consultant Job Title: Senior Manager Regulatory Affairs A leading American biopharmaceutical company in the Greater Boston area is seeking a Senior Manager of Regulatory Affairs (BLA) to join its growing team. This organization specializes in cellular therapies and specialty biologic products, with a strong focus on regenerative medicine for sports injuries and burn care. The company operates from a newly built facility and is preparing to launch several new projects in mid-next year. Key Responsibilities: Lead the development and execution of regulatory strategies for biologic products. Prepare, manage, and submit INDs, BLAs, and other regulatory filings in compliance with FDA requirements. Serve as a regulatory subject matter expert on cross-functional teams, providing strategic input and guidance. Ensure all labeling and promotional materials meet regulatory standards. Monitor evolving regulatory trends and maintain up-to-date knowledge of applicable guidelines and best practices. Represent the company in interactions with regulatory authorities, including the FDA. Qualifications: Bachelor's degree in a scientific discipline (advanced degree preferred). 5-7 years of regulatory affairs experience, specifically in biologics. Proven experience with BLA submissions, labeling, and promotional review processes. Familiarity with FDA structure, eCTD format, and combination product regulations. Strong written and verbal communication skills, with the ability to collaborate effectively across departments. A proactive, detail-oriented mindset with a passion for improving patient outcomes through innovative therapies. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionManagement IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at EPM Scientific by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles. Boston, MA $200,000.00-$230,000.00 1 hour ago Associate Director/Director of Regulatory Affairs Boston, MA $200,000.00-$230,000.00 5 days ago Associate Director/Director, Regulatory Affairs Boston, MA $172,521.00-$249,862.00 1 month ago Associate Director CMC Regulatory AffairsRegulatory Affairs Director, Global Regulatory Strategy Boston, MA $186,232.80-$279,349.19 23 hours ago Associate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Director, Regulatory Affairs - Specialty MedicineExecutive Director, Regulatory Affairs - Cell MedicineAssociate Director CMC Regulatory AffairsDirector Life Sciences Regulatory Affairs and LabelingExecutive Director, Regulatory Affairs - Cell MedicineSenior Manager/ Associate Director, Medical Operations Waltham, MA $138,400.00-$193,000.00 1 week ago Sr Manager - Operational Reporting and Analytics Cambridge, MA $138,000.00-$185,000.00 1 week ago Senior Manager, Regulatory Affairs, Operations Cambridge, MA $127,219.00-$190,828.00 1 month ago Sr. Manager, Global Regulatory PublishingManager, External and Regulatory AffairsAssociate Director, Regulatory Affairs, Advertising and Promotion We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Are you the right applicant for this opportunity Find out by reading through the role overview below. Regulatory Affairs - Recruitment Consultant Job Title: Senior Manager Regulatory Affairs A leading American biopharmaceutical company in the Greater Boston area is seeking a Senior Manager of Regulatory Affairs (BLA) to join its growing team. This organization specializes in cellular therapies and specialty biologic products, with a strong focus on regenerative medicine for sports injuries and burn care. The company operates from a newly built facility and is preparing to launch several new projects in mid-next year. Key Responsibilities: Lead the development and execution of regulatory strategies for biologic products. Prepare, manage, and submit INDs, BLAs, and other regulatory filings in compliance with FDA requirements. Serve as a regulatory subject matter expert on cross-functional teams, providing strategic input and guidance. Ensure all labeling and promotional materials meet regulatory standards. Monitor evolving regulatory trends and maintain up-to-date knowledge of applicable guidelines and best practices. Represent the company in interactions with regulatory authorities, including the FDA. Qualifications: Bachelor's degree in a scientific discipline (advanced degree preferred). 5-7 years of regulatory affairs experience, specifically in biologics. Proven experience with BLA submissions, labeling, and promotional review processes. Familiarity with FDA structure, eCTD format, and combination product regulations. Strong written and verbal communication skills, with the ability to collaborate effectively across departments. A proactive, detail-oriented mindset with a passion for improving patient outcomes through innovative therapies. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionManagement IndustriesPharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at EPM Scientific by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles. Boston, MA $200,000.00-$230,000.00 1 hour ago Associate Director/Director of Regulatory Affairs Boston, MA $200,000.00-$230,000.00 5 days ago Associate Director/Director, Regulatory Affairs Boston, MA $172,521.00-$249,862.00 1 month ago Associate Director CMC Regulatory AffairsRegulatory Affairs Director, Global Regulatory Strategy Boston, MA $186,232.80-$279,349.19 23 hours ago Associate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Director, Regulatory Affairs - Specialty MedicineExecutive Director, Regulatory Affairs - Cell MedicineAssociate Director CMC Regulatory AffairsDirector Life Sciences Regulatory Affairs and LabelingExecutive Director, Regulatory Affairs - Cell MedicineSenior Manager/ Associate Director, Medical Operations Waltham, MA $138,400.00-$193,000.00 1 week ago Sr Manager - Operational Reporting and Analytics Cambridge, MA $138,000.00-$185,000.00 1 week ago Senior Manager, Regulatory Affairs, Operations Cambridge, MA $127,219.00-$190,828.00 1 month ago Sr. Manager, Global Regulatory PublishingManager, External and Regulatory AffairsAssociate Director, Regulatory Affairs, Advertising and Promotion We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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