Regulatory Affairs Executive Job Opening 2019 @ Lupin
Regulatory Affairs Executive Job Officer Pharmaceutical Science candidates are encouraged to work in research jobs at Lupin Limited. Candidates looking for their career in the Research field may apply for this job post. Check out all the details on the same on our website Rasayanika.
Job Title: Regulatory Affairs Officer/executive
Eligibility: B Pharma/ M Pharma
Experience: 2 to 7 years
- The person will be responsible for the activities at site related to registration and regulatory affairs in USA, Europe, Australia, Brazil, ROW – including South Africa, etc.
- To provide all the necessary support to corporate RA for regulatory submissions related to formulations for all countries.
- To share the regulatory deficiencies with concerned departments and provide related response and documents to corporate RA for further action.
- To ensure regulatory compliance by providing required documentation for the submission of amendments, supplements/variations and timely Annual updates.
- 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.
- Evaluation of post approval changes for impact assessment and regulatory filings. If required, consult corporate RA and co-ordinate with other departments to understand the regulatory submission strategies.
Salary: INR 3,00,000 – 5,50,000 PA.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Senior Management
Role: Head/VP/GM-Regulatory Affairs
Employment Type: Full Time, Permanent
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