Regulatory Affairs Executive (Male)

Roche International; Mumbai City; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Roche International in Mumbai seeks an Executive - Regulatory Affairs to coordinate regulatory submissions and maintain dossiers for ROW markets. The role involves preparing CTD/ACTD materials, handling renewals and variations, and supporting post-approval submissions as part of a dynamic regulatory team.

Candidates with UG degrees (BSc/B.Pharma/Any Graduate) and familiarity with pharmacovigilance will be preferred. The position is based in Mumbai and offers opportunities in a leading pharma MNC.

Qualifications

• UG: Any Graduate, B.Sc in Any Specialization, B.Pharma in Any Specialization
• Pharmacovigilance knowledge or experience is a plus
• Experience with regulatory submissions is beneficial

Responsibilities

• Prepare, review, compile, and submit CTD/ACTD dossiers for ROW market registrations.
• Handle new product registrations, renewals, variations, and post-approval submissions.
• Perform Pharmacovigilance activities, including adverse event (AE/ADR) monitoring and reporting] ,
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Education

B.Pharma

B.Sc in Any Specialization

Any Graduate

Job description

Prepare, review, compile, and submit CTD/ACTD dossiers for ROW market registrations.
Handle new product registrations, renewals, variations, and post-approval submissions. Perform Pharmacovigilance activities, including adverse event (AE/ADR)

UG: Any Graduate, B.Sc in Any Specialization, B.Pharma in Any Specialization

Key Skills

Skills highlighted with ‘‘ are preferred keyskills

products and services to help expedite the discovery, early-stage development and safe manufacture of novel drugs and therapeutics.

Company Info

Firm in Pharmaceutical & Life Sciences Sector

Executive - Regulatory Affairs | Leading Pharma MNC | Mumbai