​​Director, Regulatory Affairs - Biologics​

Director, Regulatory Affairs - Biologics

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, Regulatory Affairs –Biologics is responsible for executing the global regulatory strategy and for the company’s biologics portfolio across the full product lifecycle, from early development through regulatory approval, commercialization, and post-approval lifecycle management. 

This position provides strategic and operational leadership for biologics Regulatory Affairs, ensuring integrated regulatory strategies that support product development, global registrations, commercial manufacturing, product supply, and continued regulatory compliance. 

The Director serves as the primary regulatory leader for biologics, providing expert guidance to cross-functional teams and senior management, anticipating regulatory challenges, and driving effective, risk-based regulatory decisions. 

The successful candidate will bring experience with biologics development, global regulatory requirements, commercial manufacturing, and lifecycle management, combined with strong leadership skills and the ability to operate effectively in a dynamic biotechnology environment. 

Schedule: Onsite Monday – Thursday in our Burlington, MA office with flexibility to work remotely on Fridays.

Key Responsibilities:

Global Regulatory Strategy and Portfolio Leadership 

• Execute global regulatory strategies for the biologics portfolio, encompassing development-stage and commercial products. 

• Provide strategic regulatory leadership throughout the product lifecycle, from early development and clinical trials through registration, commercialization, and post-approval activities. 

• Establish regulatory strategies that support business objectives, development timelines, global market access, manufacturing operations, and product supply. 

• Serve as the primary regulatory advisor for biologics programs, providing recommendations to senior leadership on regulatory risks, opportunities, and strategic decisions. 

• Represent Regulatory Affairs on cross-functional product teams, portfolio governance committees, and business planning initiatives. 

• Monitor global regulatory developments and evaluate their impact on the biologics portfolio. 

Global Product Development and Registrations 

• Lead regulatory planning and strategy for biologics development programs, including INDs, clinical trial applications, BLAs, MAAs, and other applicable global marketing applications. 

• Oversee the preparation, review, and submission of regulatory applications and supporting documentation. 

• Lead strategic interactions with FDA, EMA, MHRA, and other applicable global health authorities. 

• Provide regulatory guidance on clinical development plans, regulatory pathways, and product approval requirements. 

• Ensure alignment of clinical and nonclinical regulatory strategies throughout development and registration.  

Commercial Product Lifecycle Management 

• Lead global regulatory strategies for marketed biologics, including maintenance of marketing authorizations and implementation of post-approval changes. 

• Oversee regulatory activities supporting product enhancements, new indications, labeling changes, and geographic expansion. 

• Ensure regulatory commitments and postmarketing requirements are appropriately managed in collaboration with relevant functions. 

• Support regulatory assessments and strategies related to product quality, manufacturing, and supply-related issues. 

• Identify opportunities to optimize global regulatory lifecycle management processes and submission strategies. 

Health Authority Engagement and Regulatory Excellence 

• Serve as a senior regulatory representative in interactions with global health authorities. 

• Provide strategic direction for health authority meeting preparation, regulatory correspondence, responses to questions, and management of regulatory commitments. 

• Ensure regulatory submissions are scientifically sound, strategically aligned, and compliant with applicable requirements. 

• Promote proactive regulatory risk identification, effective issue resolution, and continuous improvement. 

Cross-Functional Collaboration 

• Establish clear priorities, performance objectives, and accountability for regulatory deliverables. 

• Oversee resource planning, workload allocation, and external regulatory support as appropriate. 

• Build effective partnerships with Clinical Development, Manufacturing, Quality, Supply Chain, Medical Affairs, Commercial, and other functions. 

Required Qualifications:

• Bachelor’s degree in biological sciences, pharmaceutical sciences, chemistry, or a related scientific discipline. 

• Minimum of 10-12 years of progressive Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including significant experience with biologic products. 

• Demonstrated experience executing global regulatory strategies for biologics across development and commercial lifecycle stages. 

• Extensive knowledge of FDA regulatory requirements for biologics, including INDs, BLAs, and post-approval submissions. 

• Strong understanding of global regulatory requirements, including EMA and other major international health authorities. 

• Demonstrated experience leading major regulatory submissions and health authority interactions. 

• Experience providing regulatory leadership for marketed products and commercial manufacturing activities. 

• Proven ability to lead cross-functional teams, influence senior stakeholders, and make sound, risk-based regulatory decisions. 

• Strong written and verbal communication, organizational, and leadership skills. 

Preferred Qualifications:

• Advanced scientific degree (MS, PhD, PharmD, or equivalent). 

• Experience with cell-based therapies, tissue-engineered products, or other complex biologics. 

• Experience working in a small or mid-sized biotechnology company. 

• Experience supporting regulatory due diligence, business development, or portfolio expansion. 

Why Vericel? 

• Mission-Driven Work: Help bring potentially life-enhancing cell therapies to patients with serious medical conditions.

• Innovative Products: Work with a first-in-class therapy backed by clinical success and provider trust. 

• Career Growth: Be a part of a growing organization with opportunities to expand your impact.

• Collaborative Culture: Join a supportive, cross-functional team that values passion, integrity, and excellence. 

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $220,000 - $240,000 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.