Managing Director at NASTECH Consulting
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Regulatory Affairs Specialist - Pharmaceuticals/Biotechnology/Clinical Research (4-7 yrs)
Regulatory Affairs Specialist from IVD industry.
Job Title: Regulatory Affairs Specialist
Job Family: Regulatory Affairs
- Provide registration support to ensure timely launch of new product line of the Client Molecular Division.
- Ensure product launch timelines are met.
- Ensure completeness of product registration dossiers according to product regulatory classification.
- Provide full support to reporting manager in terms of content review, document fulfilment checks, document preparation, filing support and archival of regulatory records.
- Prepare risk analysis and mitigation strategies of any new/upcoming requirements for business
CORE JOB RESPONSIBILITIES :
- Compile and review regulatory submissions for timely registration of new products & renewal of entire range of on-market products for AMD
- Ensure product regulatory launch plan is strictly met
- Sensitize reporting manager with inputs on possible factors which may impact the regulatory launch plan timeline of new product line for AMD
- Provide timely inputs to reporting manager in modifying product launch timeline with adequate time to implement same without any financial/resource constraints
- Identify upcoming/evolving regulatory requirements for new IVD product launch
- Work with reporting manager 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 labelling material for compliance with applicable regulations and standards
- Ensure regulatory project deadlines and performance standards are established and met
- Work on instructions from reporting manager towards timely submission of products at NIB for performance evaluation of products for the purpose of registration
- Work on instructions from reporting manager to ensure product evaluations at NIB happens smoothly
- Daily follow-up on availability of documents and work on documentation availability timeline to ensure minimal impact on regulatory launch plan for new range of products
- Work with reporting manager to successfully handle matters related to compliance to New Medical Device Rules, 2017
- Draft processes for new regulatory requirements towards effective implementation
MINIMUM QUALIFICATIONS :
Minimum Education :
Bachelor's degree in life sciences or pharmacy (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is preferred. Masters in above field will be preferred.
Education Level Major/Field of Study
MINIMUM WORK EXPERIENCE :
Experience Experience Details :
- 2 years at minimum with a regulated industry. Strong knowledge of India regulatory affairs
- Association or working experience in Central/State regulatory authority will be preferred.
- Working knowledge on requirements of Drugs and Cosmetics Act, 1940 and Rules, 1945.
- Knowledge on requirements of New Medical Device Rules, 2017
- Product knowledge on In-vitro diagnostics products will be preferred
City : Delhi
Experience : 4-6 Yrs
Annual Salary : 13,00,000 - 15,00,000 INR
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