Job Description
We are Hiring!
Assistant Manager / Deputy Manager - Regulatory Affairs (US Market, Non-Oral)
Location: Vadodara, Gujarat
Job Summary
We are seeking a highly motivated Regulatory Affairs professional to support US regulatory activities for Non-Oral dosage forms, particularly Sterile products. The incumbent will be responsible for post-approval regulatory submissions, lifecycle management, and coordination with cross-functional teams to ensure compliance with USFDA requirements.
Required Experience
- 7 to 12 years of Regulatory Affairs experience in the pharmaceutical industry.
- Hands-on experience in US Market Regulatory Affairs.
- Strong experience in Post-Approval/Life Cycle Management activities.
- Experience with Sterile/Injectable/Ophthalmic/Non-Oral dosage forms is mandatory.
- Experience in preparation and submission of PAS, CBE-30, CBE-0, Annual Reports, and other post-approval filings.
- Working knowledge of USFDA regulations, CFR requirements, and guidance documents.
Technical Skills
- Experience in Electronic Submission Management.
- Knowledge of eCTD publishing and submission processes.
- Hands-on experience with regulatory software/tools.
Qualification :B.Pharm / M.Pharm / M.Sc. or equivalent qualification.
Interested candidate can share cv on creyesha.macwan@alembic.co.in
No Referrers Available
There are currently no referrers available for this job. You can still apply, will let you know once there is any referrer available.