About the Role:

We are seeking an experienced professional in API Regulatory Affairs with strong expertise in DMF preparation, compilation, and submission for global markets (US, EU, Canada, Japan, and ROW). The role involves ensuring compliance with regulatory requirements and supporting global submissions for Active Pharmaceutical Ingredients.

Key Responsibilities:

Prepare, compile, and review Drug Master Files (DMFs) and related regulatory documentation for global submissions.

Handle query responses from regulatory agencies in a timely manner.

Coordinate with cross-functional teams including QA, QC, R&D, and Manufacturing for data collection.

Maintain regulatory compliance and ensure updates/amendments of DMFs as per market requirements.

Support audits and provide documentation as per global regulatory expectations.

Track and maintain regulatory submissions and lifecycle management of DMFs.

Required Qualification & Experience:

Qualification: M.Sc. / M.Pharm (Chemistry / Pharmaceutical Sciences preferred)

Experience: 7 15 years in API Regulatory Affairs with hands-on experience in DMF compilation and global submissions

Key Skills:

Expertise in USDMF / EDMF / CEP filing

Knowledge of ICH guidelines, regulatory frameworks, and dossier requirements

Strong documentation and communication skills.