Job Description
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1- Regulatory Management Specialist
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Key objective of the role
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Understanding of Biological regulations – Biosafety regulations in India and other countries
Understanding animal by products regulatory framework
Understanding of Biotechnology process and Biopharma manufacturing and regulatory frameworks.
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Day to day responsibilities
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More details mentioned in JD
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Work Experience / Background
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Education / Qualifications required
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M.Sc./MTech- Lifescience/biotechnology
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1) Keeping active surveillance of changing regulatory guidelins and commnucating the same to all stakeholders across functions.
2)Act as regulatory management reviewer for new product introductions
3)Product screening & product compliance from regulatory perspective to the Material / products under purview of Merck Life Science Pvt. Ltd.
4)Update and maintain the data records of drug and ABP product.
5)Training internal and external stakeholders/customers for awareness about Merck products (Chemicals, Animal by products, and various regulatory guidance as and when require.
6) Provide inputs on draft guidelines & seek clarity on revised guidelines
7) Safeguard business by keeping abreast with the latest guidelines, notifications, gazettes etc. issued by various authorities. Analyze the information and evaluate if it has any positive/negative impact on business. Share the analysis with all the internal stakeholders.
