Vericel® Corporation · 6 days ago
Director, Regulatory Affairs, Advertising & Promotion
Burlington, MA
Full-time
Hybrid
Director/Executive
$188K/yr - $235K/yr
10+ years expVericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care, committed to innovation and scientific excellence. The Director of Regulatory Affairs, Advertising & Promotion will lead regulatory oversight for advertising and promotional activities, ensuring compliance with FDA standards and alignment with company objectives.
BiotechnologyLife ScienceTherapeutics
Responsibilities
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
Qualification
Required
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 experience with promotional guidance and enforcement trends in advertising and promotion 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
Preferred
Master's degree
Global experience with promotional guidance and enforcement trends in advertising and promotion
Experience in negotiations and/or formal interactions with regulatory authorities (OPDP/APLB or equivalent)
Benefits
Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
Company
Vericel® Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$157.3MKey Investors
Eastern Capital
2018-06-07Post Ipo Equity· $74.8M
2016-12-16Post Ipo Equity· $20M
2012-03-09Post Ipo Equity· $40M
Leadership Team
J
Jonathan Siegal
Vice President and Corporate Controller
Karen Mahoney
Chief Human Resources Officer
Recent News
2026-01-15
Benzinga.com
2026-01-15
2025-11-07
Company data provided by crunchbase