Regulatory Affairs Director

7 days ago


Navi Mumbai, Maharashtra, India Domnic Lewis International Full time

We are seeking a seasoned professional to join Domnic Lewis International as our Regulatory Affairs Director.

About the Role:

  • Develop and implement regulatory strategies to ensure compliance with international regulations.
  • Collaborate with cross-functional teams to gather inputs necessary for regulatory submissions.
  • Maintain plant compliance with regulatory standards.
  • Drive business growth by achieving monthly plan goals and responding promptly to queries.
  • Analyze gaps in existing processes and update Master data.
  • Review and validate documents such as Change Controls, Stability Protocols, Clinical Trial Protocols, and Artworks.
  • Solicit feedback from countries regarding variations and ensure timely submission.
  • Manage renewals and updates.
  • Conduct regular reviews and meetings with the plant team.
  • Track and review document requirements for new filings in ROW and Emerging markets.

Requirements:

  • eCTD, CTD, Validation, ICH requirements, USFDA Filings
  • WHO Prequalification, MCC South Africa for Biological and Biotech products
  • Experience with in-licensed dossier filing and out licensing

Salary Estimate: ₹1200000 - ₹1800000 per annum (depending on experience)



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