Regulatory Manager

Job Description:

Position:         Regulatory Manager

Location:         Vapi 

Experience:     14 - 20 Years

Industries:       Pharma - API

Responsibilities:

• Define and execute regulatory strategies for API registrations in regulated markets (EU, US, etc.).

• Provide regulatory inputs during R&D, scale-up, and technology transfer to ensure compliance by design.
• Guide cross-functional teams on evolving regulatory expectations and ensure proactive planning.
• Represent the company in regulatory meetings with authorities or partners, as required.
• Assess regulatory feasibility and risks early in product development to support strategic decisions.
• Establish systems to track regulatory commitments and maintain alignment with internal audit and compliance frameworks.

• Prepare, compile, review, and submit DMFs, CEP dossiers, ASMFs, and related documentation for regulated markets.

• Manage the complete lifecycle of submissions including variations, renewals, amendments, and query responses.
• Ensure regulatory compliance of labeling, technical documents, manufacturing process descriptions, and change controls.
• Maintain global submission databases, approval status trackers, and document repositories.
• Support customer regulatory queries and provide assistance during regulatory and customer audits.
• Continuously monitor and interpret guidelines from EMA, EDQM, USFDA, MHRA, WHO, and other agencies.
• Collaborate with Manufacturing, QA, and QC to ensure batch documentation, deviations, and change controls align with regulatory requirements.
• Coordinate with third-party consultants, agents, and local representatives for country-specific submissions.

Required Skills

• Strong understanding of global regulatory frameworks (ICH, EU, US, WHO, etc.).
• Proficiency in CTD/eCTD dossiers, DMFs, CEPs, ASMFs.
• Knowledge of regulatory systems/databases: ESG, CESP, eSubmission Gateway, XEVMPD.
• Excellent technical writing and documentation skills.
• Familiarity with API analytical data, manufacturing processes, and stability requirements.

Required Qualification: - B.Sc/M.Sc/B.Pharm/M.Pharm 

Salary: - Upto 25.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-