The Senior Regulatory Specialist will join the Regulatory Affairs, Clinical and Compliance Team based at one of our Grand Island, Frederick, or Carlsbad site.
As a Senior Regulatory Specialist you will be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions (CE marking), Cell Therapy Drug Master File submissions to FDA for regulated products and provide regulatory support on development cell therapy projects.
• Compile, review and maintain regulatory submissions, Drug Master Files, Technical Documentation, and labeling to ensure the compliance of applicable regulations.
• Serves as the primary contact with Norwegian regulatory agencies for Life Technologies products.
• Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations.
• Identify regulatory requirements for changes to existing products.
• Determine the scope of information/documentation necessary to file new registration applications and post- approval changes to regulatory agencies.
• Review and approve labeling/marketing material for compliance with applicable regulations and standards.
• 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.
• Issue export documents to support customs requirements.
• Review new and existing regulations, guidance documents and standards, and prepare comments based on impact to product and business. Keep Regulatory Team and appropriate Life Technologies personnel informed of significant regulatory issues affecting Life Technologies products. Work with Life Technologies Regulatory Affairs group, provide regulatory and scientific advice to other areas of the LT Corp.
• May be required to perform other related duties as required and/or assigned.
• Develop regulatory affairs internal policies and procedures, and provide internal training when required.
Requires a Bachelor’s degree in biology or related discipline.
Proven track record in regulatory affairs, ideally with experience in: IVD Medical Devices, cell therapy, gene therapy, ancillary materials for cell, gene and tissue engineered products.
Good working knowledge of IVD/Medical Devices Regulations, standards, submissions, Technical Documentations and CE certification.
Good working knowledge of EMEA and FDA Regulations concerning submission of Biologics License Application and Applications for advanced therapy medicinal products for cell therapy products
Experience in regulatory audits, ISO certification, GMP requirements and document control.
Must interface with many levels of management in a widely varied cultural mix worldwide.
Has contact with all levels of company employees as well as regulatory authorities, customers and vendors and distributors when required.