Job Summary: We are looking for an experienced and agile Regulatory Affairs Manager to lead regulatory operations and ensure compliance with national and international pharmaceutical regulations. The ideal candidate will oversee regulatory submissions, manage product registrations, coordinate with regulatory authorities, and collaborate with cross-functional teams to support timely approvals and business objectives.

Key Responsibilities:

Lead the preparation, review, and submission of regulatory dossiers for domestic and international markets.

Ensure compliance with applicable regulatory requirements and monitor changes in regulatory guidelines.

Develop, implement, and maintain regulatory policies, SOPs, and procedures.

Coordinate with QA, QC, Production, R&D;, and Export departments on regulatory matters.

Liaise with regulatory authorities and respond to regulatory queries and deficiency letters.

Manage product registrations, renewals, variations, and regulatory approvals.

Maintain and organize all regulatory documentation and ensure audit readiness.





Provide regulatory guidance to internal teams and support regulatory inspections and audits.

Train and mentor the Regulatory Affairs team to achieve departmental objectives.

Required Qualifications: B.Pharm / M.Pharm / M.Sc. (Life Sciences)

Regulatory Affairs certification will be an added advantage.

Experience Required: 5–8+ years of experience in Pharmaceutical Regulatory Affairs.

Experience in handling domestic and international regulatory submissions is preferred.

Required Skills: Pharmaceutical Regulatory Affairs

CTD/eCTD Dossier Preparation

Domestic & International Product Registration

Regulatory Compliance

Documentation & Record Management

MS Office (Excel, Word & PowerPoint)

Leadership & Team Management

Excellent Communication & Analytical Skills

Job Location:

Angel Biogenics Pvt Ltd

216-218 "ANMOL", Opp. Nakshatra V, Sadhu wasvani Road, Rajkot - 360005

Pay: ₹15,000.00 - ₹25,000.00 per month

Work Location: In person

📌 Regulatory Affairs Officer (Rajkot)
🏢 Aksharam pharma
📍 Rajkot