Manager- Regulatory Affairs-International Domnic Lewis Pvt. Ltd

7.0 - 11.0 years

0 Lacs

maharashtra

On-site

Role Overview: As a Manager- Regulatory Affairs-International, your primary purpose will be to manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets. You will ensure ongoing regulatory compliance and support product lifecycle management across ROW and emerging markets. Key Responsibilities: - Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers. - Coordinate with manufacturing sites and R&D to gather necessary data and documents for regulatory submissions. - Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes. ...

Posted 1 day ago

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Asst Manager/ Manager- Regulatory Affairs Bharat Serums and Vaccines

8.0 - 12.0 years

11 - 15 Lacs

navi mumbai

Work from Office

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Posted 2 weeks ago

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