AM / DM - Regulatory Affairs (Non Orals) - Vadodara

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 [email removed]