Associate
Current1. Authoring and review of the CMC sections of the dossier (IND, NDA, NDS, ANDA, ANDS, MAA, BLA etc.) for assigned Biologics/ Biosimilars/ pharmaceutical products for global submissions (Global markets).2. Review of CMC source documents and provide support in conducting regulatory gap assessment as per the relevant guidelines for global submissions.3. Authoring and submission of Pre-IND/Pre-NDA/ Pre-BLA/scientific advice briefing packages for assigned products to global regulatory agencies.4. Support in preparation of CMC checklists for various types of regulatory submissions for Biologics/ Biosimilars/ pharmaceutical products.5. Authoring, review and timely submission of regulatory complaint query response for assigned products.6. Working on change control assessment and related product life cycle management activities, i.e., submission of renewals and annual reports.7. Support in regulatory strategy preparations for initial applications, variations, and HA query responses.
