Designation: Executive- Regulatory Affairs
No. Vacancies: 1
Experience: 4-5 years
Location: Vile Parle
Educational Qualification: B.Sc/ M.Sc in Chemistry
Preferred Industry: Pharmaceuticals
Reporting to: Senior Manager- Regulatory Affairs
Responsibilities:
· Collection and reviews of documents for annual updates, amendments and CEP Revisions.
· Preparations of applicant’s part and restricted part of the DMF.
· Preparations of Technical Data Packages
· Preparations of letter of access.
· Compilation of DMF/CEP/USDMF/ASMF etc.
· eCTD compilation and submissions.
· Controlling & monitoring of activities in coordination with other functional areas like QA, QC and ADL.
· RA routine activities and life cycle management.
· Handling of deficiencies/queries received from Agency /Customers.
Pay: ₹25,000.00 - ₹41,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Work Location: In person
