Regulatory Affairs Specialist from IVD industry.

Job Description

Job Title: Regulatory Affairs Specialist

ORGANIZATION

Job Family: Regulatory Affairs

Job Sub-Family:

JOB SUMMARY

- 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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