Manager Regulatory Affairs | Abbott | Delhi

Apply Now

Job Overview

  • Date Posted
    June 1, 2023
  • Location (State / UT)
  • Expiration date
  • Experience
    7 Years, 10 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description


  • This role would be accountable for routine updates for Abbott applications submitted to the Centre, State and other relevant regulatory authorities for EPD India products.
  • The responsibilities would be including but not be limited to submitting Abbott applications to Center/State/other regulatory bodies and following up with officials of these agencies for licenses, approval, and query letters.
  • This role would be considered as a highly experienced and knowledgeable resource within the organization in directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
  • Adapts precedent and may make significant departures from traditional approaches to developing solutions.
  • Comprehensive knowledge in the area of Regulatory Affairs.

Job Description:

  • Regulatory applications for follow-up of New Drugs, SND, FDC, Import & Registration, Biological, and Medical device applications filled at CDSCO.
  • Samples submissions and follow-up with IPC Ghaziabad /Zonal office Ghaziabad CDSCO /Sadiq Nagar CDSCO/NIB, Noida/CDL, Kasauli for any assigned task.
  • Prioritizing, planning, and monitoring allocated projects/applications against defined timelines.
  • Online and offline submission & collection of all communications to CDSCO/IPC/Zonal office/Sadiq Nagar CDSCO/ NIB, Noida, etc.
  • Responsible for document submission like dossier submission, PSUR, SAE, query reply, etc.
  • Responsible for follow-up of Subject Expert Committee invitations and coordinating the CDSCO for proposal.
  • Responsible for creating and updating the database for all submissions & approvals from CDSCO and other relevant govt bodies.
  • Able to perform any task assigned for CDSCO/IPC/Zonal office/Sadiq Nagar CDSCO/ NIB, Noida, etc time to time by Senior management.
  • Monitoring the notifications/notices/circulars/GSR/orders to create and update the database for further identifying the impact on business.
  • Interacts with regulatory agencies to speed up approval of pending registration.
  • Coordination with Internal Stakeholders for documentation required for Import license application and successful submission of Form 10.
  • Ensures timely approval of new drugs, Subsequent New Drugs, biologics, or medical devices and continued approval of marketed products and well versed with CMC information-related queries raised by Regulatory Authority.
  • Responsible for resolving issues of CDAC to avoid any technical glitches raised during the submission of applications in the Sugam system.
  • Regularly gets updated and self-trained with the latest regulations on drugs in the country.

Experience Details:

Regulatory Affairs exp. Minimum 7-10 years in Pharmaceuticals, Biosimilars, vaccines, etc.

Minimum Education:

B.Pharm, M. Pharm, M.Sc.