Sun Pharma hiring for India Regulatory Affairs

Job Description

We are hiring for Vadodara Site:
Function : India Regulatory Affairs
Qualification : M.Pharm or B.Pharm with 2-7 years of relevant experience.

Brief JD:
1.     Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
2.     To review specification for bulk drug and formulations as per regulatory expectation.
3.     Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.
4.     To search literature through various websites as per the application strategy.
5.     To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.
6.     To prepare executive summary for SEC referral for drugs not approved in India.
7.     To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.
8.  To file ND/SND/FDC application on SUGAM portal for getting domestic manufacturing and marketing permission / clinical trial permission etc.
9.  To review draft specimen or label and carton.
10.  To prepare prescribing information by referring international prescribing information.

Send your resume at : Rosemary.varghese@sunpharna.com