EPM Scientific

Senior Manager, Regulatory Affairs

EPM Scientific, MA, United States

Direct message the job poster from EPM Scientific

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 level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Management
Industries
Pharmaceutical 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 Affairs

Regulatory 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 Medicine

Executive Director, Regulatory Affairs - Cell Medicine

Associate Director CMC Regulatory Affairs

Director Life Sciences Regulatory Affairs and Labeling

Executive Director, Regulatory Affairs - Cell Medicine

Senior 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