Regulatory Affairs Director
7 days ago
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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