Regulatory Affairs Manager

Job Description

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:

• This position is the regulatory lead in the Life Science Solutions Group (LSG) India office, providing cross functional teams with regulatory requirements for regulatory submissions.
• Review new and existing the regulations and guidance in South Asia and prepare impact analysis as needed for projects/business in South Asia.
• Prepare and submit regulatory submissions to the Authorities in South Asia and lead type test/clinical studies where needed in support of the product filings.
• Support APAC and Global registration of the regulated products made in LSG Indian plant.
• Ensure regulatory project deadlines and required performance standards are established and met.
• Participate in Animal Health regulatory submissions and/or provide support to Global Animal Health regulatory team if needed for existing or new submission.
• Lead Post Market Surveillance of regulated products in India. Work with cross functional teams, operations and customers to resolve and implement corrective and preventive actions resulting from technical complaints.
• Support LSG Indian Plant QMS/GMP and implement regulatory affairs activities.
• Participate in company regulatory/quality audits and assist, as needed.
• Working within Global/APAC LSG Regulatory Affairs organization, provide regulatory and scientific advice to other areas within LSG business.
• Participate in appropriate exhibitions and conferences.
• Develop contacts with consultants and regulatory agencies.
• Other tasks assigned by line manager.

Minimum Requirements: Education and qualification

• Bachelor s degree or higher degree in Engineering, Sciences or Medicine.
• Over 10 years relevant experience in regulatory affairs related to Medical Device and/or In Vitro Diagnostic Device, or Pharmaceutical.

Essential Skills and Abilities

• Regulations, standards and guidelines related to medical devices / in vitro diagnostic in India, applying both strategic skills and execution.
• Strong planning and organizing registration management skills
• Skilful in communication, effective written, verbal and presentation skills in the area of regulatory affair applications.
• Excellent analytical skills, results-oriented and a creative problem solver
• Ability to work effectively and collaboratively, across cultures and functions
• Able to work under pressure and flexible working hours based on business requirements.

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Keyskills :
medical devicespost market surveillanceanalytical skillsanimal healthimpact analysiswork effectivelyproject teamssouth asiain vitropeople managementlife sciences