Director, Regulatory Affairs

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

The Clinical Trial Assistant plays a critical role in the clinical department by ensuring the accuracy, completeness, and compliance of clinical trial documentation. This role involves collaborating with various stakeholders to maintain high-quality documentation standards in accordance with regulatory requirements and organizational policies. The ideal candidate will possess strong attention to detail, exceptional organizational skills and a thorough understanding of clinical trial processes.

Schedule:

As a company that thrives on teamwork and face-to-face collaboration, Vericel follows a hybrid schedule with in-office days Monday – Thursday in our new Burlington, MA location, and flexibility to work remotely on Fridays.

Position Scope:

• Oversees, recommends and implements regulatory activities in agreement with senior management and company goals.
• Develops, recommends and implements strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
• Manages and facilitates preparation of organized and scientifically valid marketing registration applications, supplements, amendments, and variations for drugs, biologics and devices.
• Ensures regulatory submissions are maintained in compliance with regulatory requirements in close partnership with internal stakeholders and external partners.
• Represents the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Builds/maintains relationships cross-functionally to ensure effective communication & efficient implementation of regulatory activities.
• Lead cross-functional project teams and provide expertise on regulatory matters.
• Develops and maintains current regulatory knowledge and advise management of significant developments.
• Contributes to improvements in department best practices and SOPs.
• Performs other duties as required, interfacing with other departments, CROs, and external vendors as needed.

Staff Management:

• Collaborate with leadership team in meeting corporate, site goals and objectives.
• Establish key performance indicators, maintain, and report applicable department or organizational metrics.
• Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
• Provide guidance and oversight to external consultants.

Qualifications:

• Bachelor of Science in a scientific discipline; Master of Science (preferred)
• 10 years direct Regulatory Affairs experience.
• Prior experience managing regulatory staff and providing strategic guidance
• Experience with drugs, biologics and/or medical devices.
• Previous experience with combination products and/or botanicals a plus.
• Experience with prescription drug advertising regulations and promotional review committee’s
• Working knowledge of FDA regulations and understanding of FDA structure and function.
• Working knowledge of eCTD elements and structure.
• Strong regulatory writing skills and verbal communication skills.
• 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.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement
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.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.