Regulatory Affairs Expert

3 days ago


Gurgaon, Haryana, India SUN PHARMA Full time
Job Overview

Sun Pharma is seeking an experienced Regulatory Affairs Expert to lead our CMC Product team. In this role, you will be responsible for ensuring timely submission of annual reports and supplements to regulatory authorities.

About the Role

We are looking for a seasoned professional with 10-15 years of hands-on experience in regulatory affairs. You will work closely with cross-functional teams to deliver all regulatory milestones for branded products developed for advanced markets like US, EU & Canada.

Key Responsibilities
  • Lead the development of CMC Regulatory Strategy Documents for complex projects.
  • Manage execution of CMC documentation, including PIND/IND/CTA, original NDA/MAA, and agency background packages.
  • Provide regulatory leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal.
  • Support new technology development within Sun Pharma.
  • Critical reviewing of detailed scientific information and assessing technical arguments presented clearly and conclusions adequately supported by data.
Requirements

To succeed in this role, you must have:

  • A strong understanding of regulatory affairs and related fields (e.g., manufacturing, analytical, quality assurance).
  • Excellent communication and interpersonal skills with ability to direct multi-departmental functions.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems.
  • Proven experience working in R&D CFT and managing a team of team members.
  • Proficiency in English; additional language skills are a plus.
What We Offer

As a Regulatory Affairs Expert at Sun Pharma, you can expect a competitive salary range of ₹25-35 lakhs per annum, depending on your experience and qualifications.



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