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Regulatory Coordinator

External
gsknch logoGsknch · Hyderabad Connaissance Park
Full-timeOn-site2d ago
AgileCompliance
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About the role

The purpose of this role is to support CMC product responsible in executing CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.

Responsibilities

  • Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities (including variations and renewals) for assigned product portfolio, such as mentioned below,
  • Accomplish and assist CMC product responsible in carrying out "administrative" tasks
  • Work towards improving quality of the information available in our databases
  • Internal Compliance checks: Review of the PROTRAC (internal tracker which monitors CMC has completed all the steps from WI/ SOP till dispatch date) on fortnightly basis.
  • Update standard requirement table & assist in archiving the CMC/ Regulatory surveys
  • Baseline/ Eurasia dossier by creating the CMACs / TMACs/ Normative documents/ etc.
  • Follow-up with key/ major LOC/BUs in discussion (as necessary): For Veeva update on submission / approval dates. For ex. For GREEN project, CMC is responsible for following with LOC/BUs as necessary.
  • Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
  • Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls.
  • Why you?

Requirements

  • Degree in a pharmaceutical or life science or equivalent regulatory experience - Science, Life Sciences - Medicinal/Medical Device/Cosmetic Regulation
  • 3+ years' Regulatory Affairs experience in systems, regulatory information management, compliance and ideally OTC experience
  • Ensures basic level of scientific/regulatory understanding
  • Job Posting End Date
  • 2026-06-30
  • Equal Opportunities
  • The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.
  • Adjustment or Accommodations Request
  • Note to candidates
  • The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.

Benefits

Health insurance

Additional Information

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.


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