Executive - Regulatory Affairs

Job Description:

Responsibilities

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

Qualification & Experience

• M. Pharm
• Experience
• Tenure : 2 – 4 Yrs.