Job Description

Assistant Manager/Manager Regulatory Affairs

Job Summary:

The person will be responsible for managing end-to-end regulatory activities for domestic and ROW markets. The role involves dossier preparation, regulatory submissions, lifecycle management, audit readiness, and close coordination with cross-functional teams and third-party manufacturers to ensure compliance with applicable regulatory standards.

Key Responsibilities:

• Preparation and submission of dossiers for India (CDSCO/FDA) and ROW markets
• Handling product registrations, renewals, and variations
• Coordination with internal teams (F&D, QA, Production) for OSD products
• Managing regulatory documentation for third-party products (injectables & syrups)
• Follow-up and response to regulatory queries
• Review of artwork, labels, and pack inserts as per regulatory requirements
• Coordination with CMOs for document collection and compliance alignment
• Keeping track of regulatory updates and implementing changes

Key Skills & Competencies:

• Dossier preparation & compilation (CTD/ACTD)
• Good understanding of regulatory requirements (India & ROW)
• Ability to handle work independently in a dynamic setup
• Strong coordination and follow-up skills
• Good understanding of cGMP and pharmaceutical manufacturing processes.
• Exposure to PICS and regulatory audits.

Mandatory Requirements:

• Must have hands-on experience in domestic regulatory affairs as well.
• Plant visit is mandatory (monthly or as required).
• Experience in handling PICS and other regulatory audits.
• Exposure to ROW markets is required

Preferred Candidate Profile:

• B.Pharm / M.Pharm preferred with relevant regulatory experience.
• Experience in formulation (OSD) manufacturing is a must.
• Experience in handling multiple dosage forms will be preferred
• Ability to handle regulatory activities independently.

What We Expect:

• Hands-on approach (not just documentation)
• Ability to manage multiple projects at a time
• Ownership of regulatory activities end-to-end.

More Info

Education