Regulatory Affairs- Officer | M.J.Biopharm Pvt. Ltd. | Nariman point

Role & responsibilities Contractual Role for 6 Months.

1. Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market.
2. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format.
3. Internal communication & follow-ups with various departments for various documents.
4. To arrange and send samples for registration purpose to various countries.
5. Review at all quality data received from various departments before using in dossiers and technical packages.
6. Preparation and submission of Query response raised by the Health Authority.
7. To undertake any other assignment given by superior of the department / management from time to time.
8. To support in documentation in national and international tenders.
9. Management of Product Database. Archival of dossier.
10. For COPP Application- Support with documents.

Preferred candidate profile

Must be from Formulation background

interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9619744167.

Perks and benefits