Job for Sr. Executive in Regulatory Affairs at Sentiss Pharma

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 : Research Scientist

Job Description
- To co-ordinate for all inputs required in finalizing registration/re-registration dossiers for various countries as per the requirement and review the same.
- To prepare and compile the registration/re-registration dossiers & amendments for submission in US / EU
- Handling of queries related to registration and re-registration of product
- To review plant documents, R&D documents & periodic review documents
- To handle internal audit
- To provide technical guidance to other team members
- Preparation and revision of departmental SOPs
- To review Drug Master Files
- Co-ordinate for samples and standards for registration/re registration of product
- To review and sign off bilingual COAs
- Keep HOD up-to-date on status of specific project.

 

Additional Information:
Experience: 3-5 years
Location: Gurgaon
Education: M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: Regulatory Affairs
End Date: 0th July, 2017

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