Regulatory Affairs Associate
About this role
Regulatory Affairs Associate
Role Summary
This role is responsible for Regulatory Affairs aspects of product life cycle management (PLCM) related to post approval submissions and drug product registrations. The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint.
Key Role Specific Requirements
- Manage regulatory maintenance activities for approved NADA and ANADA products.
- Maintain approved NADA and ANADA applications throughout the product lifecycle.
- Compile and submit:
- Annual reports
- CMC submissions
- Labeling supplements
- Correspondence with regulatory agencies
- Maintain regulatory records, submission archives, commitments, and approval histories.
- Ensure compliance with applicable regulations, guidance documents and approved filings.
Read the full description on TalentApply
Create a free account to see the complete job description, how well your CV matches this role, and apply in one click.
AI rewrites and formats your CV so it reads well and gets past screeners.
Get your match percentage for this exact role before you spend time applying.
Send a polished application in one click — no retyping the same details.
Follow every application in one place instead of digging through your inbox.
Free account · No card required
Your next opportunity starts here
Prepare, apply, track, interview and get hired — all from one platform, with AI in your corner.