Manager, Regulatory Affairs

---

Job description

How will you make an impact?

• Thermo Fisher is seeking a Regulatory Affairs professional to join the exciting area of cell culture media manufacturing and supporting customers in regulated markets such as biopharmaceuticals and cell and gene therapy. This position will provide regulatory support for the manufacturing site and extended project teams located at Grand Island, NY. The incumbent will ensure adherence to established processes, policies and procedures and make improvements where necessary.
• You will have the opportunity to interact with Thermo Fisher Scientific colleagues all over the world and have the ability to influence organization's global policies and procedures to improve regulatory compliance.
• Title is dependent upon experience.

What will you do?

• Liaison with product management organization and customer to understand customer requirements for custom products to ensure compliance.
• Work with functional teams to understand custom product feasibility and review and approval custom product order to ensure compliance with product specifications and use of product.
• Work closely with the Product Management team and customers to provide guidance on their request for custom variations of or catalog product; new packaging, add or subtract raw materials, for use in their development and final manufacturing of vaccines, drugs, and cell or gene therapies.
• Compile, review and maintain regulatory submissions, Technical Files, Drug Master 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.
• Participate in annual product reviews and provide guidance on raw material fit for purpose in customer vaccine, drug, or cell and gene therapy finished products.
• Partner with customers as needed to provide guidance and support for their CMC sections within their product filings.
• 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 (FDA, ISO, Notified Body)
• Participate in customer audits/technical meetings when applicable.
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.

How will you get here?

• A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science without relevant direct experience.

Experience Requirements:

• Must have a minimum of 3 years of Regulatory Affairs experience in Pharmaceutical or Medical Devices.
• Experience with complaint handling and recall reporting is highly desirable.
• Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Direct and positive experience in communicating with Regulatory Authorities and internal partners.
• Good communication skills to work directly with customers
• Regulatory review of promotional marketing materials, press releases, labeling, etc.
• Demonstrate in-depth understanding of technical/scientific principles related to Pharma and IVD reagent chemistry.
• Capacity to communicate regulations to technical functions within the company

<!– job description page –>