Regulatory Affairs-api

2COMS Consulting Pvt. Ltd.
  • Gurgaon
  • Confidential
  • 2-6 years
  • Views
  • 27 Feb 2017

  • Compliance/ Regulatory, Legal

  • Bio - Tech
Job Description

To review the manufacturing end data of Exhibit Batches of New APIs as well as Post-approval changes of Existing APIs taken at Gurgoan for regulatory adequacy & provide to corporate DRA in a timely manner for various regulatory and customer filings and queries in a timely manner.
To review Change Controls pertaining to process, quality & equipment related matters and Q-Info extensions of Key Raw Materials/Key Reactants of various APIs manufactured at Gurgoan.
To ensure Regulatory Compliance of Exhibit Batches of APIs to be filed in DMF, ANDA batches, DMF Update / Amendment / Variation batches of Gurgoan.
To ensure data generation of API / Intermediates in line with approved protocol requirements & provides regulatory support during regulatory audits at various manufacturing sites of Sun Pharma.

Assessment and Planning of Work:
The job function primarily starts with the planning for data collation upon receipt of requirements from corporate DRA and based on the targeted dates for filing.
The person has also to ensure compliance of manufacturing end data with regulatory requirements/ commitments during commercial manufacturing for ANDA and Update batches.

For meeting the regulatory filing and Compliance objectives, the key internal contacts are as:
Corporate DRA (Bulk): Associate Director and his / her team this is primarily to discuss the filing requirements.
API (Manufacturing): General Manager/Sr. Manager and their teams this is primarily to discuss and obtain data for filing requirements viz., manufacturing process, equipment list with details and also to discuss regulatory impact of the change controls that they raise.
Quality Assurance/Control: Director/General Manager/Sr.Manager and their teams this primarily to discuss and obtain filing requirements viz., MPRs, executed BPRs, COAs, Stability data with details.

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2COMS Consulting Pvt. Ltd.