AddressWe are hiring dynamic 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 strong 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.
