Regulatory Affairs

Role & Responsibilities
• Compile, review, and submit regulatory dossiers in eCTD format for US FDA, EU, CDSCO, and other regulated markets
• Manage Drug Master Files (DMFs) including preparation, updates, amendments, and full lifecycle management
• Maintain and update regulatory databases for submissions, lifecycle changes, LOAs, Applicant Parts, and Restricted Parts
• Plan and submit annual reports, variations, amendments, and regulatory changes within defined timelines
• Prepare and submit responses to regulatory authority and customer queries
• Issue No Objection Certificates (NDCs) and ensure timely regulatory database updates
• Review and approve change controls, deviations, and QMS documentation
• Ensure compliance with global regulatory requirements for APIs and Peptides

Qualification
• M.Pharm / B.Pharm

Experience
• 8–15 years of experience in Regulatory Affairs
• Experience in API and Peptides manufacturing
• Hands-on experience with US FDA, EU, and CDSCO regulatory requirements

Skills
• Strong knowledge of global regulatory frameworks and DMF submissions
• Expertise in eCTD compilation and lifecycle management
• Strong analytical and documentation skills
• Excellent communication and stakeholder coordination abilities
• Project management and leadership skills
• High attention to detail and compliance orientation

About the Company
Piramal Pharma Limited is a leading global pharmaceutical company known for innovation in API manufacturing and complex generics. The company operates with a strong focus on quality, compliance, and patient-centric solutions across regulated markets including the US and Europe. With a culture built around “Design Your Destiny,” Piramal Pharma offers a collaborative environment, professional growth opportunities, and a commitment to regulatory excellence.