Regulatory Affairs

1 day ago

Ahmedabad, Gujarat, India Kashmik Formulation Private Limited Full time

Department: Regulatory Affairs

Industry: Pharmaceutical (API)

Experience: 2–5 Years

Qualification: M.Pharm / B.Pharm / M.Sc / B.Sc (Chemistry / Pharmacy)

Location: As per company requirement

Job Summary

We are seeking a Regulatory Affairs – API professional to manage regulatory submissions, documentation, and compliance activities related to Active Pharmaceutical Ingredients (APIs) for global markets, ensuring adherence to international regulatory requirements.

Key Responsibilities Regulatory Submissions

  • Prepare, review, and submit DMFs (USDMF, CEP, ASMF)
  • Compile CTD/eCTD dossiers for API registrations
  • Manage responses to regulatory agency queries (USFDA, EDQM, EMA, WHO, etc.)

Documentation & Compliance

  • Maintain up-to-date regulatory documentation and lifecycle management
  • Review change controls, deviations, and CAPAs from a regulatory impact perspective
  • Ensure compliance with ICH, cGMP, and global regulatory guidelines

Regulatory Intelligence

  • Monitor and interpret regulatory guidelines and updates
  • Assess impact of regulatory changes on existing filings

Audit & Inspection Support

  • Support regulatory audits and inspections
  • Coordinate with QA, QC, R&D, and Manufacturing for compliance activities

Client & Agency Coordination

  • Act as a point of contact for customers and regulatory agencies
  • Support customer regulatory requests and questionnaires

Required Skills & Knowledge

  • Strong knowledge of API regulatory requirements
  • Hands-on experience with DMF filing and lifecycle management
  • Understanding of ICH guidelines, GMP, and data integrity
  • Excellent documentation and communication skills

Job Types: Full-time, Permanent

Benefits:

  • Food provided
  • Provident Fund

Work Location: In person

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