Regulatory Affairs Specialist- Delhi

Location: Delhi, Delhi, India
Date Posted: 11-07-2018
Job Description
Division: Molecular Division  
Job Title: Regulatory Affairs Specialist
                               
ORGANIZATION
Job Family: Regulatory Affairs               
Division: Molecular
 
JOB SUMMARY
  • Provide registration support to ensure timely launch of new product line of Abbott Molecular Division (AMD).
  • 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 busines
 
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

Candidate Profile
Candidates from IVD Industry are required

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.

MINIMUM WORK EXPERIENCE
  • 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

 
Kind Regards,

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