Regulatory Affairs Manager / Assistant Manager

V C Shah Patel Services; Vadodara; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Asence Pharma Private Limited in Vadodara is seeking an Executive / Assistant Manager - Regulatory Affairs to lead DMF/ASMF/eCTD dossier preparation and defend regulatory queries. You will coordinate with R&D, QC, QA, Production, Warehouse and Marketing teams to ensure timely submissions and robust responses.

The role requires an understanding of evolving regulatory guidelines and a commitment to compliance, making you a pivotal link between multiple departments in the organization.

Qualifications

• UG: B.Pharma in Any Specialization.
• PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization.
• Regulatory affairs experience in preparing/reviewing DMF/ASMF/eCTD dossiers is preferred.

Responsibilities

• Prepare/review DMF/ASMF/eCTD dossiers
• Handle regulatory queries and deficiency responses
• Coordinate with R&D, QC, QA, Production, Warehouse & Marketing teams
• Monitor regulatory guidelines and compliance

Education

B.Pharma

MS/M.Sc(Science)

M.Pharma

Job description

Executive / Asst Manager - Regulatory Affairs (RA)

• Prepare/review DMF/ASMF/eCTD dossiers
• Handle regulatory queries and deficiency responses
• Coordinate with R&D, QC, QA, Production, Warehouse & Marketing teams
• Monitor regulatory guidelines and compliance

Role Category: Pharmaceutical & Biotechnology

Education

UG: B.Pharma in Any Specialization

PG: MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization

Key Skills

Skills highlighted with ‘‘ are preferred keyskills

Asence Pharma Private Limited is an active, unlisted private company headquartered in Vadodara, Gujarat, incorporated on 14 December 2004. The company operates as a key manufacturer and global distributor of Active Pharmaceutical Ingredients (APIs)