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RA Manager

Apply 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 dossiersDrive “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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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