Senior Team Member – Regional RA | Cipla | Vikhroli

Job Purpose:

•  Original Dossier review, compilation & submission.
• Product life cycle management (renewals, retentions, Variation submissions)
• Ensure timely product approval and ensure availability of compliant product for placing on market

Role & responsibilities:

• Contribute to the regulatory strategy for CGA countries by participating in the team discussion and providing regulatory input as per the current guidelines during the initial phase of development till the submission of the dossier  to ensure correct documentation and data generation
  • Provide the necessary information and other preliminary details like the batch size details and the minimum packaging requirement to the cross-functional team.
  • Provide RA input for requirements of CGA countries during the product development phase
  • Inform them about the document requirement to the stakeholders and provide necessary information on the newly published guidelines to the team
  • Co-ordinate with the different departments for multiple documents required & implement chosen regulatory submission procedure to ensure approval from the agency within targeted timelines
• Review of the submission and associated documents as per the current regulatory requirement to ensure the correctness of the same for compliance with the regulatory health authorities’ requirement of filing
  • Review and assist in preparing the dossier to ensure all the relevant documents are present in the dossier ensuring the completeness of the dossier which will ensure quick approval from the agency
  • Review, compilation, and submission of the dossiers for CGA core (WHO & USFDA).
  • Module 1 preparation and finalization for Regulatory Health submission for CGA core + CGA countries.
  • Monitor the document flow from the Internal cross-functional team and External Customers, to ensure that the timelines are met
  • Track receipt of deficiency received from MOH and respond to the received from Customers and internal stakeholders to ensure that the dossier deficiency responses are submitted on time
  • Track the product approvals and ensure it is received in the defined timeline.
• Maintain the market authorization throughout the product life cycle to ensure compliance with product quality and safety and by renewing validity to ensure the availability of the product in the market
  • Evaluate the proposed changes to the submitted dossier and proposals for post-approval changes to determine/validate the appropriate category of change
  • Review, compilation, and submission of the variations for CGA core.
  • Review, compilation, and submission of the requalifications for CGA core.
  • Module 1 preparation and finalization of variation packages Amended dossier to ensure quick approval of variations from the MOH.
  • Track and submit the product renewal dossiers within the validity expiry date for the applicable countries.
  • Track and apply for the product retentions within the required timeline for the applicable countries.
•  Maintain the database associated with the DOS by including all the details in the database for ease of product history
  •  Provide the status of the various products during the life cycle to the cross-functional team as when requested
  • Maintain the regulatory database (Viz: PRC database & GPL)
  • Follow regulatory SOPs.
• Support Business, Internal cross-functional team, and External Customers w.r.t technical/regulatory aspects to ensure smooth supply and product serviceability
  •  Maintenance of RA tables in a timely manner as per request from Business
  • Provide required regulatory information to businesses for tenders & RFQs.
  • Raise labeling change controls in a timely manner.
  • Regulatory support to PV  to meet pharmacovigilance requirements of the region
  • Provide timely regulatory (Labelling) information to Global Drug Safety
  • Provide timely product information to applicable stakeholders
• Maintain the database associated with the DOS by including all the details in the database for ease of product history
  •  Provide the status of the various products during the life cycle to the cross-functional team an when requested
  • Maintain the regulatory database (Viz: PRC database & GPL)
  • Follow regulatory SOPs.
• Support Business, Internal cross
  • Communicate with external stakeholders, and LTRs to ensure the timely MOH submissions of dossiers, variations, and renewals.
  • Continuous engagement with LTRs for dossier status updates, receiving product approvals, and variation approvals in time.

Education Qualification & Relevant Work Experience

B. Pharmacy, M. Pharm, MSc

14 years of experience in the regulatory affairs department in a Cipla in the emerging market / SAGA region.