HomeProductionRegulatory Affairs & Quality Assurance Manager | Abbott Laboratories | Mumbai

Regulatory Affairs & Quality Assurance Manager | Abbott Laboratories | Mumbai

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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position: Regulatory Affairs & Quality Assurance Manager

Location: Mumbai, Maharashtra, India

Job Description:

Primary Job Function:

  • Compile and review regulatory submissions for timely registration of new products & renewal of the entire range of on-market products for India
  • Ensure product regulatory launch plan is strictly met
  • Provide inputs on possible factors which may impact the regulatory launch plan timeline of the new product line for AMD
  • Provide timely inputs when there is a need to modify product launch timeline with adequate time to implement the same without any financial/resource constraints

  • Identify upcoming/evolving regulatory requirements for new IVD product launch
  • Serve as AM RA representative in industry/regulatory meetings
  • To maintain good contact and ensure timely follow-up with Indian regulatory agencies
  • Determine the scope of information/documentation necessary to file new registration applications and post-approval changes according to existing checklists to regulatory agencies
  • Review product labeling material for compliance with applicable regulations and standards
  • Ensure regulatory project deadlines and performance standards are established and met
  • Ensure timely submission of products at NIB for performance evaluation of products for the purpose of registration
  • Draft processes for new regulatory requirements towards effective implementation
  • Coordination for Local testing for the purpose of generation of performance evaluation reports from Central Medical Testing Laboratory. Ensure receipt of IVD kits for submission to the National Institute of Biologicals, Noida, follow-up of reports and communication of related issues to Abbott and coordinate with NIB for newer plans of testing and improving future business relations with NIB, etc. Ensure receipt of Invoices against payment done

Qualification: B.Pharma/M.Pharma, A diploma in Regulatory Affairs is preferred.

Experience: 5-7 Years

Salary: Negotiable

Contact Details:

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