Require Regulatory Affairs Manager at Takeda

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Post : RA Manager

Job Description
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.

Additional Information
Location : Gurgaon
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
Job ID : SR0047326
End Date : 25th March, 2020