We are hiring agile regulatory affairs talents with capabilities in CMC and regulatory intelligence.

Responsibilities
Direct global clinical, non-clinical, and CMC regulatory strategies.
Preparation of submission dossiers in CTD/eCTD for US FDA and EU.
CMC writing/review, EU/ANDA/NDA/IND submissions.
Development/regulatory driven development plan on clients products.
Experience with other key markets like CANADA and China desirable

Requirements
M.Pharma - Other Specialization/ MS/M.Sc(Science) - Bio-Chemistry/ Medical-MS/MD - Any Specialization/Ph.D/Doctorate - Any Specialization
Ph.D/Doctorate - Any Specialization
BVSC - Any Specialization/ BHM - Any Specialization/ BHMS - Any Specialization/ B.Pharma - Pharmacy/ BAMS - Any Specialization/ Other Graduate - Other Specialization
MS/M.Sc(Science)



- Biotechnology/ Agriculture/ Bio-Chemistry/ Biology/ Botany/ Chemical Engineering & Materials Science/ Chemistry/ M.Pharma - Any Specialization/ M.Tech - Environmental/ Instrumentation/ Bio-Chemistry/Bio-Technology/ Biomedical/ Chemical
Author, review and edit regulatory documents and packages for submissions to national regulatory authorities (NRAs) and/or scientific or executive management meetings
Serve as the lead writer for high priority submissions such as Scientific advice meeting briefing materials/PIP/IMPD/IND submissions and amendments
Involvement in Training and development.
Experience in core regulatory function for US/EU/CANADA markets is preferred.
Detail oriented person, with solid capability to multi-task
Experience with developmental CMC of solids /sterile injectables/ eyedrops /respiratory products
Involve in training and development activities as and when required.
Participate in client discussions.

📌 Manager Regulatory Affairs Us And European Market Kochi
🏢 Silmed Scientific
📍 Kochi