When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
• Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality.
• Identifies regulatory requirements for new product and changes to existing products.
• Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations.
• Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.
• Review new and existing regulations, guidance documents and standards, and prepare comments based on impact to product and business.
• Support post-market surveillance and vigilance activities.
• Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits.
• Participate in customer audits/technical meetings when applicable.
• Develop regulatory affairs internal policies and procedures, and provide internal trainings as and when required.
• Bachelor’s degree in Applied Sciences (Biology or Chemistry) or similar field such as Pharmacy or Medical Sciences, from an accredited college or university or equivalent industry experience• 5+ years' experience
• A strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions, Recalls and Technical Files.
• Experience of communicating with Regulatory Authorities
• Experience in regulatory audits, ISO certification, GMP requirements and document control.
• Experience in preparing DMFs, specifically eCTD submissions is desirable
• Experience with USDA or EU requirements for Animal By Products is desirable
• Working knowledge of excipients and CMC requirements for cell and gene therapies is desirable
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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