Microbioligist jobs in Delhi - Star Tech S India 

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  • Job View 8 Views
  • Applicants Less than 5 Applicants
  • 2019-01-09

Job Description

Lead and execute the regulatory strategy for biological products for ROW countries.

Dossier preparation & submissions for biological product in ROW countries as per business plan.

Responsible for Regulatory Affairs of vaccines, bio-therapeutics, enzymes & antibiotics.

Responsible for Registration filing with DCGI & WHO and would be involved in new product registrations.

Dealing with Clinical Trial submissions and post approval changes.

Preparation of application on Form 8, 9, 12, 40, 44, 27-D, Wholesale Licenses and renewal of licenses wherever applicable.

Preparation of application for grant of GMP/COPP/FSC/Non-Conviction Certificate, Capacity Certificate, Technical Staff Approvals and renewal of licenses wherever applicable

Preparation of documents for attestation from SDCA(State Drug Control Authority ) for the Tender purpose

Preparation and compilation of dossier for RCGM submission for obtaining NOC from chemical trials & CITES NOC from DGFT

Key Skills



Functional Area

Medical / Health Care / Hospitals

Number of Vacancy



Diploma, Professional Degree

About Star Tech S India 

STS INDIA A multi-disciplinary HR consulting and recruitment firm in India. Flexible and innovative HR solutions that persistently meet and exceed the expectations of the clients.

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