HomeRegulatory AffairsExecutive- API Regulatory Affairs | Rusan Pharma | Mumbai Suburbs | 3.00-6.00...

Executive- API Regulatory Affairs | Rusan Pharma | Mumbai Suburbs | 3.00-6.00 L

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Rusan is a research-driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients, and Intermediates. The company has its own Research & Development center at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar, and Formulation plant at Dehradun and SEZ, Kandla having the approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 – 82 Crs., Expected by March 2009 150 Crs.

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Position: Executive- API Regulatory Affairs

Location: Mumbai Suburbs, Maharashtra, India

Job Description:

Roles and Responsibilities

  • Preparation and submission of responses on customer / Health Authorities Query as per current regulatory requirements.
  • Preparation of Applicant part/Technical package for customers and ensure all regulatory documents incorporated in the applicant part of Technical package.
  • Issuance, maintenance, and Tracking of the database for LOA, CEP, LOE, LOC, LOA to CEP, and other essential Declarations requested by the customer.
  • Review of registered DMFs, amendments, and annual reports submitted to regulatory authorities for revising the applicant parts and providing updated documents to customers.
  • Work as part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products.
  • Maintaining and ensuring the database to keep a track of intimations and notifications forwarded to all concerned customers and respective marketing person.
  • Overview of Specification, Test Methods, Analytical Method Validations, and Customer Compliments related to the regulatory market.

Desired Candidate Profile

    • The candidate should be M.Sc./ B. Pharma.
    • Must have worked into QC or ADL for a minimum of 2 years.

Qualification: MS/M.Sc

Experience: 3-7 Years

Salary: 3,00,000 to 6,00,000 INR CTC/PA

Contact Details:

hrmumbai@rusanpharma.com

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