Home Regulatory Affairs Executive to Asst Manager | Regulatory Affairs | Intas Pharmaceuticals | Ahmedabad

Executive to Asst Manager | Regulatory Affairs | Intas Pharmaceuticals | Ahmedabad

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Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon.

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With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors. A variety of initiatives in Research and Development, patents and ANDA filing, NDDS, quality manufacturing support, along with approvals by regulatory authorities of many countries has made Intas a global healthcare provider. Pioneering efforts in providing medications for both chronic and acute medical conditions have truly led Intas to live up to its corporate line Expressions for a Healthy Life.

Position: Executive to Asst Manager

Location: Ahmedabad, Gujarat, India

Job Description:

  • Evaluation, preparation, review, and compilation of CMC (Chemistry, Manufacturing, and Control) documentation in line with the latest regulatory requirement.
  • To identify the document required for submissions at regulatory agencies and clients by negotiating the delivery of approved technical source documents in accordance with project timelines.
  • Preparation and review of DMF (Drug Master File) related documents from the initial developmental stage till product registration considering DMF regulatory strategies and regulatory compliance within predefined timelines.
  • eCTD submission of Drug Master File considering region-specific requirements, response to queries, amendments, annual reports to regulatory authorities.

  • Lifecycle management of allocated APIs.
  • Preparation and review of responses or additional information or deficiencies of CMC required by customers and regulatory authorities.
  • Notifying clients as well as agencies for significant changes in the CMC part via change notification, variations, amendments, technical packages, renewals, and annual reports, etc, and providing client support for faster registration followed by approval.
  • Review of change control and other documents (vendor documents) for assessing the impact on DMF.
  • Interdepartmental Coordination with R&D, QA, QC, ADL, and production for documents required for regulatory submission to various authorities.
  • Keeping knowledge up to date with regard to the latest regulatory guidelines and regulatory as well as technical trends and sharing with API team members.
  • If any other work assigned by the reporting manager.

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

Experience: 5-10 Years

Salary: Negotiable

Contact Details:

careers@intaspharma.com, job@intaspharma.com,

ashishn_mehta@intaspharma.com

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