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Work as Regulatory Affairs Product Lead at Shire

 

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Shire traces its history back to 1986, when a small team of entrepreneurs sought out a solution to address on a number of unmet medical needs. Within its first two years of operation, the company had launched a range of supplemental calcium products for patients seeking to treat or prevent osteoporosis. Soon thereafter, innovative drug development programs were under way on behalf of patients facing such challenging conditions as Alzheimer's disease and end-stage renal failure.

Post : Regulatory Affairs Product Lead

Job Description
Job Summary 
The RA Product Lead is responsible for preparation of regulatory submissions, approvals and strategies in accordance with the applicable rules and regulations. He/she executes regulatory activities relating to registration requirements, renewals and product life cycle maintenance for India and neighboring geographies – Sri Lanka, Bangladesh, Nepal and Pakistan.

  1. Leads preparation, submission and negotiation of approval Indian regulatory submissions (e.g., NDA, variation, renewal, CTA, CTA Amendments, Early access request, responses to HA questions), including content / structure definition, preparation / review / collection of components, and submission review.
  2. Acts as primary contact with Health Authorities for assigned products
  3. Collaborate with Global Regulatory Affairs for required documents for preparation of regulatory dossiers
  4. Drive country regulatory strategies in alignment with company business goals ensuring timely registration of all new products for market growth and renewal of existing product licenses in timely manner to ensure business continuity.
  5. Develop & execute RA strategy as per law of land for India and other adjoining geographies to ensure compliance & market continuity.
  6. Attends Health Authorities meetings, leading preparation for these meetings and of meeting-related materials.
  7. Drive “Concept to Commercialization approach” and ensure complete ownership of “Product life cycle maintenance”- (Includes Registration, Renewals, Ad-prom review, Change Control, CCDS, Trackers & Matrices, RATS update, variation filing, labeling compliance, timely release of product from port & testing laboratories & tender support) & timely execution of all projects.
  8. Monitor & drive toward full compliance as per company policy & standards, applicable laws and regulations requirements as per law of land of India & adjoining geographies.
  9. Monitor regulatory changes and assess their impact and advice strategies to mitigate negative influence and timely communicate all these changes to global & regional RA and country leadership team.
  10. Establish strong relationship with key members of country regulatory agencies to facilitate technical and strategic discussions related to product approvals and license maintenance and win-win relationship with all industry groups.
  11. Review and approve Advertising and Promotional materials for all products to ensure regulatory compliance.
  12. Evaluation, submission and follow-up of applications for registration of new products, renewals & variations, according to the relevant guidelines and regulations.
  13. Maintain and update centralized/local database for products registered in India and adjoining markets.
  14. Keeping abreast with the evolving/upcoming regulatory changes, analyzing the impact on the organization, and implementing & executing RA strategy to operationalize changes- getting an early understanding of how the organization will be affected by changes in regulation at an early stage can bring real and tangible benefits to company that identify competitive advantages arising from these changes and implement cost effectively will gain market position.
  15. Ability to collaborate with different functions (Marketing, Sales, Quality Assurance & Supply Chain) to understand the business and commercial priorities.
  16. Review, compilation and on time submission of documents to ADC and NIB required for import and further testing of biological products.
  17. Co-ordination with tender & sales team for providing complete tender support.

 

Additional Information:
Req ID: R0013341
Category: Regulatory Affairs
Location: Gurugram, Haryana IN

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