Hello Connections,
Hiring!!
Department – Regulatory Affairs
Education – B. Pharm / M. Pharm
Designation – Jr. Officer to Sr. Executive
Job Location – Mumbai / Indore
Industry – Pharmaceuticals
Roles –
* CTD & ACTD dossier preparation, review and their timely submission for African countries, Latin America etc.
* Co-ordination with plant / QA / R&D / QC for timely catering to documents / sample requirements for regulatory submissions
* Review & archival of data
* Review Artwork and Label as per respective country guidelines.
* Life cycle Management of approved drug products:
– Timely preparation and submission of annual reports/renewals.
– Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies
– Regulatory Compliance- Ensure timely implementation of regulatory decisions for change management and other activities in DF plants.
Skills Required –
* Minimum 3 to 5yrs of experience.
Interested candidates can send their updates CV on girish@sfil.in or call on 9340128202
Best Regards,
Girish Kalani