Saikat Das
Regulatory Affairs consultant
Talent
Vadodara, Vadodara30 INR/hourMember since October 7, 2024
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Regulatory Affairs consultant
About
- Craft, review, and refine technical documents for regulatory submissions, ensuring alignment with applicable guidance.
- Responsible for the creation, assembly and publishing of major and minor variations (PAS, CBE-0, CBE-30, Type IA/IB/IA-IN)
- Coordination of various departments and manage submissions for prompt FDA responses.
- CMC authoring related to Module 2 and Module 3 for US submissions as per request.
- Creation of eCTD sequence and life cycle management for various companies.
Software expertise: Veeva Vault, Docubridge, PharmaReady
- Creation of artworks and labeling texts as per the global country specific requirement.
- Preparation of the application form for clinical trials online from scratch to submission via SUGAM portal. Review of the CMC documents and preparation of the set of documents based on the latest updated guideline of New Drug and Clinical Trials Rules and further submission.
- Regulatory submission consulting regardless of market of concern like EU, UK, Middle East and ASEAN region.
