Job Title: Officer/Exe-Regulatory
No. of Posts: 1
Salary: INR 2,00,000 – 4,00,000 P.A.
1. The person will be responsible for all the activities at site related to registration and regulatory affairs .
2. To provide all the necessary support to corporate RA for regulatory submissions related to API for all countries.
3. To share the regulatory REQUIREMENTS with concerned Departments and provide related response and documents to Corporate RA for further action.
4. To ensure Regulatory compliance by providing required documentation for the submission .
5. To review and approve all master documents and review of executed documents (like Specifications, Test Methods, Batch Production Records, Stability Protocols and Reports, etc) prior to submission.
6. Evaluation , changes for impact assessment and regulatory filings. If required consult corporate RA and co-ordinate with other departments to understand the regulatory submission strategies.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Project Manager-Production/Manufacturing/Maintenance
Employment Type: Permanent Job, Full Time
UG -B.Pharma – Pharmacy, Any Graduate – Any Specialization
PG – MS/M.Sc(Science) – Any Specialization, Chemistry
Doctorate – Doctorate Not Required