Executive/ Sr. Executive- Regulatory Affairs- API & Formulation (RA)

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.
• Good 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.