JOB DESCRIPTION

Job Title: Executive / Officer-Regulatory Affairs
Location : Dombivli
Experience : 3 – 5 yrs
Qualification : MSc. (Org./Ana.), Diploma in RA preferred

Purpose of Job:

Product registrations with different authorities/ Countries and regulatory documentation.

JOB PROFILE :

1. Visit websites of regulatory bodies like FDA, EDQM, CANADA, TGA, EMEA, UKMHRA etc. and download the important and relevant information.
2. Compilation and preparation of DMF closed part, annual updates, amendments, revision/renewals documents.
3. Review technical packages and open part DMF prepared for customer.
4. Maintain Activity Log.
5. Respond to queries raised on technical data packages and DMF open part.
6. Review of SOPs related to RA.

Desired Profile :

Candidate should have knowledge of ICH guidelines, DMF preparation in CTD format.