Manager, Regulatory Affairs
Manager, Regulatory Affairs
The Manager, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. This position will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.
• With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
• Manage the assembly and timely submission of INDs, BLAs, MAAs and other dossiers as required for investigation and registration of medical products in the US and abroad.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements.
• Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Participate on project teams and provide expertise on regulatory matters.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Assist in SOP generation and contribute to improvements in department best practices.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.
Qualifications, Education, Experience:
• Bachelor of Science in a scientific discipline.
• 3+ years direct Regulatory Affairs experience for pharmaceutical, biotech, or medical device products in the US market.
• Combination product experience a plus.
• Experience and knowledge in preparation of INDs, BLAs, and supportive amendments and supplements.
• Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function.
• Working knowledge of eCTD elements and structure.
• Strong regulatory writing skills and use of Microsoft Word.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
• Possess excellent written and verbal communication skills.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.