Regulatory Affairs Specialist
Thermo Fisher Scientific is seeking an experienced Regulatory Affairs Specialist. Areas of focus include Class I and II medical device regulatory compliance and supporting customers in regulated markets such as biopharmaceuticals and cell and gene therapy. This position will provide regulatory support at the manufacturing site and extended project teams located at Grand Island, NY. The incumbent will work in the Global Regulatory Affairs department and will be responsible for site regulatory compliance, managing site regulatory inspections and regulatory meetings, and author final product submissions. These activities are key to supporting our Bioproduction and Biosciences business through the utilization of our Grand Island products globally. In addition, incumbent will ensure adherence to established processes, policies and procedures and make improvements where necessary.
Position Objective Overview:
Provides Regulatory Affairs guidance/support to Thermo Fisher Scientific project teams and Grand Island manufacturing site. Main activities include ensuring local site regulatory compliance, providing regulatory support to project teams during new product development, determining submission requirements, facilitating and authoring regulatory documents and subsequent meetings, as well as authoring final submission packages such as 510k or Drug Master Files. The delivery of regulatory guidance to the business, project teams, and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department and will have direct line reporting to a Sr. RA Manager.
When you’re part of the Regulatory Affairs team at Thermo Fisher you’ll do rewarding work, like helping customers gain regulatory approvals for breakthrough therapies, in vitro diagnostic device development or liaising directly with global regulatory authorities to ensure product compliance. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Working for the world’s largest life sciences company ensures you will experience an exciting variety of work and exposure to innovative technologies.
• 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.