Job Description

Department:

Regulatory Affairs

Industry:

Pharmaceutical (API)

Experience:

2-5 Years

Qualification:

M.Pharm / B.Pharm / M.Sc / B.Sc (Chemistry / Pharmacy)

Location:

As per company requirement

Job Summary

We are seeking a

Regulatory Affairs - API

professional to manage regulatory submissions, documentation, and compliance activities related to

Active Pharmaceutical Ingredients (APIs)

for global markets, ensuring adherence to international regulatory requirements.

Key Responsibilities Regulatory Submissions

Prepare, review, and submit

DMFs (USDMF, CEP, ASMF)

Compile

CTD/eCTD dossiers

for API registrations Manage

responses to regulatory agency queries

(USFDA, EDQM, EMA, WHO, etc.)

Documentation & Compliance

Maintain up-to-date regulatory documentation and lifecycle management Review

change controls, deviations, and CAPAs

from a regulatory impact perspective Ensure compliance with

ICH, cGMP, and global regulatory guidelines

Regulatory Intelligence

Monitor and interpret

regulatory guidelines and updates

Assess impact of regulatory changes on existing filings

Audit & Inspection Support

Support

regulatory audits and inspections

Coordinate with QA, QC, R&D, and Manufacturing for compliance activities

Client & Agency Coordination

Act as a point of contact for

customers and regulatory agencies

Support customer regulatory requests and questionnaires

Required Skills & Knowledge

Strong knowledge of

API regulatory requirements

Hands-on experience with

DMF filing and lifecycle management

Understanding of

ICH guidelines, GMP, and data integrity

Excellent documentation and communication skills
Job Types: Full-time, Permanent

Benefits:

Food provided Provident Fund
Work Location: In person