Role & responsibilities

- Preparation, compilation, review, and submission of regulatory dossiers for API and Formulation products for US and ROW markets.

- Preparation, review, and maintenance of Drug Master Files (DMF) and related regulatory documentation for API products.

- Compilation and submission of regulatory documentation in CTD/eCTD format as applicable to the respective markets.

- Support regulatory submissions, registrations, amendments, variations, renewals, and other post-approval activities for API and Formulation products.

- Coordinate with cross-functional teams such as R&D;, QA, QC, Production, and other relevant departments for collection and review of technical data required for submissions.

- Preparation and compilation of responses to queries from US FDA, other Regulatory Authorities, and Customers.

- Review of analytical, manufacturing, quality control, and technical documents for regulatory submissions.

- Maintain and update regulatory documents, submission trackers, databases, and regulatory records.

- Ensure regulatory documentation is prepared in compliance with US and applicable ROW regulatory requirements and guidelines.





- Track submission timelines, regulatory queries, approvals, and commitments and ensure timely completion of regulatory activities.

- Coordinate with internal and external stakeholders for regulatory submissions and query responses.

Candidate Profile

- Experience in Regulatory Affairs for API and/or Formulation products for US and/or ROW markets.

- Experience in US Regulatory Affairs / US FDA submissions will be an added advantage.

- Experience in API Regulatory Affairs and DMF will be an added advantage.

- Positive knowledge of CTD/eCTD structure and regulatory submission requirements.

- Understanding of US FDA, ICH, and applicable ROW regulatory guidelines.

- Experience in handling regulatory queries and responses.

- Good documentation, communication, coordination, and analytical skills.

- Ability to work effectively with cross-functional teams and manage multiple regulatory activities.

- Strong attention to detail and ability to work within defined submission timelines.

📌 Executive/ Sr. Executive- Regulatory Affairs- API & Formulation (RA) (Mumbai)
🏢 Enaltec
📍 Mumbai