HomeRegulatory AffairsSr Executive Regulatory Affairs (API) | Unichem Laboratories | Mumbai

Sr Executive Regulatory Affairs (API) | Unichem Laboratories | Mumbai


Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to delivering better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug company with an increasing focus on cutting-edge research and developed markets.

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With formulations constituting the core of the company business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability.

Position: Sr Manager – Regulatory Affairs

Location: Mumbai

Job Description:

  • Compilation of applicant and restricted parts of DMFs to regulated and non-regulated markets.
  • Submission of application for CEPuu
  • Life cycle management of DMF and CEP
  • Review of documents and technical data for new submissions for compliance with the current expectations of regulatory agencies and compliance with ICH, FDA, EDQM, EMA, MHLW, and other regulatory agencies.
  • Review of development report for QbD for submissions.
  • Review of deficiencies and co-ordination with internal and external customers
  • Co-ordination with both internal and external customers, to respond to these satisfactorily.
  • Review of change controls, deviations, and handle the associated regulatory implications.
  • Notification of changes to customers of DMF and CEP for an amendment to DMF, variation to CEPs, and any associated changes. Maintenance of records of notification.

Desired Knowledge & Skills

  • Well versed with FDA, ICH, EMA, EDQM, MHLW and other regulatory agencies guidelines
  • Hands-on experience on eCTD software

Qualification: B.Pharma/M.Pharma

Experience: 5-8 Years

Salary: Negotiable

Contact Details:


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