RA ManagerApply Now Email Me Job ID SR0039849 Date posted 08/01/2019 Location: Gurgaon, India
The role exists to prepare Regulatory Submissions, approvals and strategies in accordance with the applicable rules and regulations. The individual will execute all the regulatory activities related to registration requirements, Renewals and products lifecycle maintenance for India and neighboring countries ( Sri Lanka, Bangladesh & Nepal) as per Business needs. Incumbent is expected to act in compliance with country policies and practices to reduce company’s exposure to Regulatory risks.
ACCOUNTABILITIES•Leads preparation, submission and negotiation of approval for Indian regulatory submissions, including content / structure definition, preparation / review / collection of components, and submission review. Acts as primary contact with Health Authorities for assigned products. •Collaborate with Global Regulatory Affairs for required documents for preparation of regulatory dossiers•Drive “Concept to Commercialization approach” and ensure complete ownership of “Product life cycle maintenance”- (Includes Registration, Renewals, Change Control, Variation filing, labeling compliance, timely release of product from port & testing laboratories & tender support) & timely execution of all projects. •Review, compilation and on time submission of documents to ADC and NIB required for import and further testing of biological products.
CRITICAL SUCCESS FACTORS & KEY CHALLENGES
·Business partner mindset·Acceleration of Product registrations and licenses·External stakeholder relationships & management·Documentation·Cross-functional collaboration
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