Regulatory Affairs

India Permanent View Job Description
The Regulatory Affairs professional would be responsible for handling dossiers for new products including biosimilars, innovators, and complex generics in India.
  • Opportunity to work on impactful healthcare projects across diverse geographies
  • Remote working opportunity

About Our Client

Our client is a global healthcare company committed to providing high-quality, affordable pharmaceuticals and healthcare solutions across emerging markets.

Job Description

  • Management and coordination with Indian vendors of technical and legal requirements for getting the marketing authorization approval at the Health Authorities in LATAM countries.
  • Pre-Audit and Audit of the dossier for new applications of products from India to be submitted in LATAM countries.
  • Strong follow up with indian vendors, by email, by phone or by personal meetings in order to comply and deliver each of the technical and legal documents needed to comply regulatory plan in a timely manner.
  • Coordinate regular meetings between internal RA team and Vendor´s RA team to follow-up the ongoing projects
  • Coordinate with Indian vendors the shipment of samples and original hard copies of documents required for the submission in each country.
  • Coordinate with Indian vendors to develop any special requirement such as transport validations, In vivo or In Vitro bioequivalences to comply with special regulation in the region

The Successful Applicant

  • Proven experience in handling portfolio submissions from a regulatory affairs standpoint, including evaluation of multiple contractors
  • Strong communication and collaboration skills
  • Demonstrated ability to work independently with a results-driven approach

What's on Offer

The company fosters a dynamic and agile work environment where employees are encouraged to take ownership, innovate, and grow rapidly within the organization.

Quote job ref
JN-062025-6763222

Job summary

Function
Healthcare & Life Sciences
Sub Sector
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
India
Job Type
Permanent
Job Reference
JN-062025-6763222

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.