Roles and Responsibilities of Senior Manager – Regulatory Affairs

• 1. New Product Registration

  • Support Head of RA in preparing slides w.r.t regulatory pathway for new product registration / post approval commitments
  • Search for information on competitor products, ongoing clinical trials, SEC data etc
  • Prepare summary report on any potential generic infiltration.
  • Prepare responses to queries raised by Area/ Global on the proposed regulatory pathway.
  • Collaborate with the Area and Global for documentation for new product registration for all stages of registration for marketing in India.
  • Collaborate and work on the presentation slides for Subject Expert Committee Meetings
  • Arrange discussion and rehearsals with the Subject Matter Experts before the Subject Expert Committee Meetings
  • Support Head of RA during the actual presentation in the Subject Expert Committee Meeting
  • Circulation of the minutes of the meetings to the stakeholders and co-ordinate on the next steps or any action items
  • Work closely with the Global SMEs on any query raised by the Agency for timely response submission.
  • Work closely with the Reference standards team for sample procurement for testing purpose
  • Co-ordinate with the laboratory for submission of samples and testing completion
  • Submission of testing reports to the office of CDSCO and follow up on the final approval.
  • Circulation of the approval to relevant stakeholders and Updation of database
  • In case of any post approval commitment, co-ordinate with the SMEs on the completion of post approval commitment.

   

  2. Site Registration Certificate and Import Licences

  • Ensure timely submission and approval of renewal of the licences.
  • Guide Submission Manager to work on the documentation required for licence renewals.
  • Review final documentation before submission.
  • In case of any query receipt from the Agency, review the queries and guide the Submission Manager on circulation to Area.
  • Take part in the query discussion kick off meetings and agree on the timelines for submission.
  • Review final query response document from Global, support Submission Manager to prepare locally driven responses.
  • Approve the responses in COSMOS before Submission Manager proceeds with submission to Agency.

   

  3. Institutional Business

  • Review requests received from Institutional Business team.
  • Discuss with the Managers on the requirement and guide them on the same.
  • Review of submission cover letters, clarification letters and finalize the same
  • Support team during their absence to provide response to the Institutional Business Team

   

  4. Licence Lifecyle Maintenance activities (CMC variations, CCDS updates)

  • Review and provide timely inputs on all CC assessments received from Area for India region.
  • Agree with the Area on the submission and approval timelines.
  • Work closely with the Submission Manager to ensure receipt of relevant documentation from CMC
  • Review final documentation before submission.
  • In case of any query receipt from the Agency, review the queries and guide the Submission Manager on circulation to Area.
  • Take part in the initial and query discussion kick off meetings and agree on the timelines for submission.
  • Review final query response document from Global, support Submission Manager to prepare locally driven responses.
  • Approve the initial assembly and responses in COSMOS before Submission Manager proceeds with submission to Agency.
  • In case of any CCDS updates, review the proposed changes and complete assigned country disposition task as per defined timelines.
  • Work with the team for updation of the PI
  • Review the updated PI before circulation for QC check process
  • Approve the PI as per the internal QC check process
  • Ensure timely submission to Agency.
  • Guide submission managers and inform the manufacturers on the defined implementation timelines.

   

  5. NPPA- Pricing related activities

  • Work closely with the consultant and internal team members on any responses to queries raised by the NPPA or any other Agency for both scheduled and non scheduled formulations pertaining to product shortage, non availability, overcharging, litigation.
  • Work with finance and other stakeholders on annual price updates as per policy
  • Notification to NPPA on any product discontinuation
  • Providing product related information to the consultant for updation in IPDMS

   

  6. Artwork Review and Approval

  • Communicate changes and the timelines if any to the team.
  • Work with the team on the project initiation on PAMS/AMS.
  • Review the artwork for final approval as per internal process

   

  7. Product discontinuation

  • Based on the communication received from the SCM, communicate to relevant stakeholders on the product discontinuation
  • Work with the team to ensure timely notification to the manufacturer, submission of notification to Agency, licence cancellation and updation of the database.

   

  8. Distribution Market

  • Guide the Distribution Market Manager on every activity associated with these countries – new product registration, licence lifecycle maintenance activities such as renewals, CMC variations, labelling updates.
  • Help team member to draft/ review responses to CMC or any other stakeholder on the documentation requirements, historic data or country specific requirements.
  • Participate in the monthly meetings.
  • Directly work with the distributors on certain critical matters

   

  9. Audit support

  • Active participation in the departmental Audit
  • Taken ownership to work closely with the team for pre-audit preparation.
  • Anticipate potentials areas of concerns during audit.
  • Active participation during F2F audit – preparation of responses during audit, post audit response /CAPA submission for the findings.

   

  10. Team Management

  • Ably managed team for SL, NP and BGD
  • Guided the team on company systems, processes as well as regulatory requirements to help them navigate their assigned roles and responsibilities.