Regulatory Affairs

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

Qualification
• M.Sc / M.Pharm ( Master of Pharmacy) / B.Pharm (Bachelor of Pharmacy) from a recognized institution

Experience
• 8–15 years of experience in Regulatory Affairs
• Strong experience in API / Peptides manufacturing
• Hands-on experience with DMF submissions and lifecycle management for US FDA, EU, and CDSCO

Skills
• In-depth knowledge of global regulatory requirements (US FDA, EU, CDSCO)
• Expertise in DMF preparation and submission processes
• Strong understanding of APIs and Peptides regulatory frameworks
• Regulatory database management and documentation control
• Analytical thinking and problem-solving ability
• Strong communication and leadership skills
• Ability to manage multiple projects in a fast-paced environment

About the Organization
Piramal Pharma Limited is a leading global pharmaceutical company specializing in APIs, complex generics, and contract development and manufacturing services, committed to innovation, regulatory excellence, and patient-centric healthcare solutions worldwide.