Senior Manager, Regulatory Affairs

Log in Register Contact Us 14712 Sinclair Circle, Suite C Tustin, CA 92780 (949) 679-3329 Social LinkedIn Twitter Facebook Instagram Tel 949-679-3329 Login / Register Senior Manager, Regulatory Affairs Apply Now Senior Manager, Regulatory Affairs Ref #: 350 Location: North Carolina Salary: 130,000 Per Annum Sector: Regulatory Affairs Type: Fixed What you will be doing: Serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy Timely management and preparation of high quality regulatory documents and submissions Regulatory life-cycle management for licensed products (e.g. preparation, coordination and submission of variations/supplements/annual reports, facility/product registrations) Act as the company's primary point of contact for FDA Establish effective working relationships with Regulatory Agencies and major regulatory consulting agents Management of Commercial requests to ensure content of promotional materials is compliant with applicable regulations Ensure regulatory applications comply with applicable regulations and guidance documents Coordinate the Health Authority response team Prepare and organize advice meetings with regulatory authorities Represent regulatory as member of Project Team(s) and assure RA input into designated projects Our ideal candidate will have: Advanced life science degree (MS, PhD) 8+ years of regulatory affairs experience required, preferably experience with biologics Experience in regulatory submissions and post-authorization life-cycle management Sound knowledge of FDA guidelines Proven direct interactions with FDA Please apply today! Back Home About Us Clients Candidates Jobs Patient Impact Blog Contact Us Where we are 14712 Sinclair Circle, Suite C, Tustin, CA 92780 (949) 679-3329 info@clinlinks.com Follow Us Privacy Policy Terms & Conditions 2026 ClinLinks Inc. All Rights Reserved × CV Upload