Established in the early 90's, this organization has emerged as an integrated pharmaceutical company offering products to the global market. Headquartered at Delhi NCR, India and plant in North India, the Company develops, manufactures and markets a wide range of quality products in diverse area of treatment.Over the years, the organization has positioned itself as a significant player in the Russian and CIS markets and has expanded its foothold in the US, Europe, India and other markets. The key competitive advantage lies in having the Research & Development centre together with the world class manufacturing facility that has enabled it to provide end-to-end solutions from product development to marketing. The manufacturing facilities are approved by many regulatory bodies including EUGMP and WHOGMP thereby allowing the company to reach International markets.
Post : Senior Executive/Asstt. Manager- Regulatory Affairs
Job Description
1. Review and submit the Abbreviated New Drug Applications (ANDA) for US market and submit the Marketing Authorization Applications (MAA) for EU region.
2. Initiate the submission of all the dossiers in eCTD format across US and EU.
3. Initiate the submission of eLabeling i.e., SPL and PLR for US market.
4. Review and submit responses for the queries received from the USFDA and EU regulatory agencies.
5. Review and submit the supplements & variations for filing the post approval changes in the US and EU region.
6. Review the analytical document of raw material and finished products specifications & test procedures, packaging material specifications & test procedures, in-process specifications & test procedures, analytical method validation protocols and reports etc.
7. Review the development documents like master formula records, product development reports and stability protocols etc.
8. Review the plant documents like batch manufacturing records, process validation protocols and process validation reports etc.
9. Ensure the compliance of the registration dossier in line with the practice at plant.
10. Update the team members by providing various presentations on regulatory topics.
Additional Information:
Experience: 3+ years
Location: Gurgaon
Education: M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Regulatory Affairs
End Date: 30th October, 2017
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