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Internal Vacancy Title | 1- Regulatory Management Specialist |
Working Hours / Shift | General |
Location | Jigani, Bangalore |
Contract Duration | 1 Year |
Key objective of the role | 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. |
Day to day responsibilities | More details mentioned in JD |
Work Experience / Background | 1- 2Years |
Education / Qualifications required | M.Sc./MTech- Lifescience/biotechnology |
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.
Rangam India (Rangam Infotech Pvt. Ltd.), a subsidiary of US-based Rangam Consultants Inc., was incepted in 2005 as an information technology company in Vadodara, Gujarat. We have a branch office in Ahmedabad, Gujarat and satellite offices in Bengaluru, Karnataka and Kolkata, West Bengal. We provide staff augmentation, customized software development and educational services to clients in India.
Job ID: 146458691