MSN Laboratories is amongst the world’s fastest-growing Pharmaceutical Company having 9 API Plants. MSN crated Benchmarks in Developing Complex drugs, Economically feasible, Making it No -1 in active DMF’s in the world.

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Position: Executive/Sr Executive Regulatory Affairs

Location: Hyderabad

Division: API

Job Description:

  • Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D, and Production.
  • Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]
  • Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA, etc.
  • Thorough knowledge and hands-on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe, etc
  • Hands-on experience in preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.
  • Should have knowledge of product development and the quality systems to ensure regulatory compliance.

  • Should have hands-on experience on eCTD regulatory submission tools.
  • Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge of the requirements to respond to the deficiencies. Ensuring that accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
  • Thorough review and ensuring that the regulatory submissions are adequate and error-free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
  • Participation in the cross-functional team meetings and providing regulatory inputs to the Product Development Teams.
  • Reviewing the documents received from various departments R&D, AR&D, QA, QC and Production, etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
  • Review and assessment of change controls and providing guidance to the team on proposed changes.
  • Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.

Qualification: B.Pharma, M.Pharma/M.Sc

Experience: 6-10 Years

Salary: Negotiable

Contact Details:

simhachalam.piniminti@msnlabs.com, hr@msnlabs.com

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