Director, Regulatory Affairs, Advertising & Promotion Job at Vericel in Burlingt

Overview

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 Director of Regulatory Affairs, Advertising & Promotion will own and drive regulatory leadership and oversight for advertising, promotional, and non-promotional activities supporting cell therapy, biologics, combination products and medical devices. This individual will be responsible for ensuring that all promotional materials and communications are scientifically accurate, compliant with FDA and other global regulatory standards, and aligned with company objectives. The role requires strong expertise in regulatory requirements for advanced therapies and combination products, the ability to chair and guide promotional review processes, and proven leadership in cross-functional and regulatory authority interactions.

Schedule

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

Position Scope

Enable the business by providing regulatory guidance and oversight for U.S. and global advertising and promotional activities supporting cell therapy, biologics, combination products and medical devices.

Leverage strong written / verbal communication skills to review and approve all promotional, non-promotional, and scientific materials to ensure accuracy, fair balance, and compliance with applicable regulations.

Partner and build strong relationships cross-functionally with Medical, Legal, Quality, and Commercial to ensure promotional content is scientifically rigorous and compliant.

Chair high-volume Medical, Legal, Regulatory (MLR) meetings for Vericel's brands sharing the regulatory perspective with the goal of enabling business and mitigating risk.

Serve as primary contact and SME with FDA OPDP / APLB and other health authorities.

Maintain deep expertise in FDA regulations, guidance documents, and enforcement actions pertaining to advertising and promotion; monitor regulatory developments and communicate changes and implications to internal stakeholders.

Ensure the promotional review process is efficient, consistent, and aligned with regulatory expectations, with the goal of supporting business agility while minimizing compliance risk.

Develop, implement, and continuously improve processes, SOPs, and best practices for the review and approval of advertising and promotional materials, including integrating new AI technologies.

Provide training and education to internal teams on requirements for prescription product promotion.

Partner with and advise product development and brand teams on advertising and promotional considerations during product development, launch planning, and lifecycle management.

Participate in or lead regulatory project team and labeling meetings, providing strategic input on promotional implications of proposed labeling, new claims, and campaign concepts.

Qualifications

Bachelor of Science in a scientific discipline; Master's degree preferred.

10+ years direct Regulatory Affairs experience with at least 5+ years of experience in regulatory review of promotional materials for prescription drug or biologic products.

Proven track record in managing promotion review committees (e.g. PRC) or other regulatory governance forums.

Deep knowledge of FDA / OPDP / APLB regulations, global promotional guidance and enforcement trends in advertising and promotion.

Experience in negotiations and / or formal interactions with regulatory authorities (OPDP / APLB or equivalent) preferred.

Demonstrated ability to collaborate and influence cross-functionally (Medical, Legal, Commercial, Quality) and drive alignment under regulatory constraints.

Strong team player that has a customer service approach and is solution oriented.

Attention to detail, strong written and verbal communication skills and the ability to work individually, within a multidisciplinary team.

Experience authoring and implementing SOPs, review processes, training materials for promotional compliance.

Proven success in managing large, complex, time-sensitive projects in a regulated environment.

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.

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