Manager, Science

Purpose:

The position will be based out of Indore and will work on post approval regulatory filings for all markets including compiling supplements/variations, answering queries from regulatory agencies, liaising with the cross-functional teams and manufacturing sites to obtain needful documents for product registration.
Position / Job Title - Manager/Sr. Manager
Department - Regulatory Affairs
Reporting To - GM, Regulatory Affairs
Location - Thane
Years of Experience - 8-12 years
Dosage Form - Any dosage form

Job Responsibilities / Deliverables
- Preparing and submitting regulatory post approval filings in the US including CBE-0, CBE-30 and PAS supplements as well as Annual Reports and PADERS and similar post approval filings in other countries.
Reviewing all submission documentation and authoring dossier sections.
Liaising with the cross-functional teams and manufacturing plants for documents for registration and reviewing them.
Addressing any queries or deficiencies from the regulatory agency and ensuring approvals in the shortest time.
Ensuring the post approval filings are submitted and registered as per the schedule.
Reviewing change controls and classifying changes as per the regulatory guidelines.
Qualifications & Pre-Requisites
- Experience in post approval regulatory filings
Should be an M.Pharm/M.Sc
Good communication and planning skills.
Additional notes
- Will need to work in different shifts.
Need to visit manufacturing sites.