Sr. Manager/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: 

Opportunity for a regulatory professional looking to grow beyond submissions and into enterprise-level strategic influence, this role provides meaningful learning, strong development support, and the chance to shape how innovative therapies are responsibly communicated to healthcare providers and patients.

This is an outstanding opportunity for a strong Regulatory professional who wants to broaden their impact and build a highly valuable specialty skillset in Advertising & Promotion. While prior A&P expertise is not required, this position offers structured exposure, mentorship, and hands-on experience in one of the most visible and strategically important areas of Regulatory Affairs. You will gain direct insight into how regulatory strategy translates into real-world messaging, how labeling decisions influence commercial execution, and how to balance compliance with competitive positioning.

This role will provide strategic regulatory leadership and oversight for advertising, promotional, and non-promotional communications supporting cell therapy, biologics, combination products and medical devices. You will work closely with Commercial, Medical, Legal, and Quality leaders, expanding your cross-functional influence and executive visibility. The role also provides the opportunity to deepen your understanding of FDA enforcement trends, risk assessment, and regulatory interpretation in a dynamic, fast-paced environment. 

In addition to A&P regulatory activities, this individual contributes to broader regulatory strategy and ensures alignment between labeling, promotional claims, and regulatory submissions.

Schedule: 

This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. 

Drive continuous improvement of regulatory processes, SOPs, and best practices while maintaining current knowledge of evolving regulatory requirements and enforcement trends.

The individual in this role will undergo structured development to assume primary responsibility as the Regulatory Reviewer for Advertising & Promotion materials. Development will include:

Regulatory Strategy & Cross-Functional Leadership

• Lead and implement regulatory strategies to support timely approvals and lifecycle management.
• Oversee preparation and maintenance of compliant regulatory submissions (applications, supplements, amendments, and variations) in partnership with internal and external stakeholders.
• Represent the company in interactions with FDA and other health authorities, providing expert regulatory guidance on development, post-marketing, and promotional matters.
• Ensure alignment between labeling, regulatory strategy, and advertising/promotional claims, including input into labeling negotiations and governance discussions.

Basic Qualifications:

• 8 years Regulatory Affairs experience. 
• Experience with biologics/drugs, combination products and/or medical devices preferred. 
• Experience in negotiations or formal interactions with regulatory preferred.

• Demonstrated ability to influence cross-functionally (Medical, Legal, Commercial, Quality) and drive alignment under regulatory constraints.
• Experience authoring and implementing SOPs, review processes, training materials for promotional compliance.
• Advanced analytical, communication, negotiation, and decision-making skills.

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.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $188,000 to $235,000 annually.

The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

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.