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Job Location | Bangalore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD |
EmploymentType | Full-time |
About Thermo Fisher ScientificThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com THE POSITION: The Regulatory Affairs Manager is responsible for preparing accurate, clear and concise regulatory documents; and for providing knowledgeable input to interdisciplinary project teams and management. You assess current/emerging regulations, guidance documents and corporate/industry standards for impact on the business area. You collaborate effectively with partners across project teams, their party vendors and/or development partners to ensure effective project communication and coordination for submission assignments and special projects. The role will call for a strong strategic orientation, an understanding of how the regulatory affairs function both drives commercial outcomes and ensures compliance with operating codes and ethical principles, and great people management skills. You develop and maintain excellent talents and knowledges of procedures and environment related to Regulatory Affairs, and establish and maintain a network with the relevant policy makers and regulatory agencies. Job responsibilities:
Keyskills :
medical devicespost market surveillanceanalytical skillsanimal healthimpact analysiswork effectivelyproject teamssouth asiain vitropeople managementlife sciences