Director, Regulatory Affairs - Biologics

Vericel Corporation • Burlington, MA

1d • Hybrid

About The Position

The Director, Regulatory Affairs – Biologics is responsible for executing global regulatory strategy for Vericel’s biologics portfolio across the full product lifecycle, from early development through regulatory approval, commercialization, and post-approval lifecycle management. The role provides strategic and operational leadership, ensuring regulatory strategies support product development, global registrations, commercial manufacturing, product supply, and ongoing compliance. The Director is the primary regulatory leader for biologics, advising cross-functional teams and senior management, anticipating regulatory challenges, and driving effective, risk-based decisions.

The position leads regulatory planning and submissions for biologics development programs and marketed products; directs engagement with global health authorities; and provides regulatory guidance across clinical development, manufacturing, quality, supply, labeling, and lifecycle activities. It also establishes priorities and accountability for regulatory deliverables, oversees resource planning and external support, and builds partnerships across the organization.

The schedule is onsite Monday through Thursday at the Burlington, Massachusetts office, with flexibility to work remotely on Fridays.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Execute global regulatory strategies for the development-stage and commercial biologics portfolio.
• Provide 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.
• Advise 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.
• Lead regulatory planning and strategy for development programs, including INDs, clinical trial applications, BLAs, MAAs, and other global marketing applications.
• Oversee preparation, review, and submission of regulatory applications and supporting documentation.
• Lead strategic interactions with the FDA, EMA, MHRA, and other applicable global health authorities.
• Provide regulatory guidance on clinical development plans, regulatory pathways, and product approval requirements.
• Ensure clinical and nonclinical regulatory strategies are aligned throughout development and registration.
• Lead lifecycle strategies for marketed biologics, including maintenance of marketing authorizations and implementation of post-approval changes.
• Oversee regulatory activities for product enhancements, new indications, labeling changes, and geographic expansion.
• Ensure regulatory commitments and postmarketing requirements are managed with relevant functions.
• Support regulatory assessments and strategies related to product quality, manufacturing, and supply issues.
• Identify opportunities to optimize global regulatory lifecycle management processes and submission strategies.
• Provide strategic direction for health authority meeting preparation, regulatory correspondence, responses to questions, and regulatory commitment management.
• Ensure regulatory submissions are scientifically sound, strategically aligned, and compliant with applicable requirements.
• Promote proactive regulatory risk identification, effective issue resolution, and continuous improvement.
• Establish priorities, performance objectives, and accountability for regulatory deliverables.
• Oversee resource planning, workload allocation, and external regulatory support as appropriate.
• Build partnerships with Clinical Development, Manufacturing, Quality, Supply Chain, Medical Affairs, Commercial, and other functions.

Benefits

• Bonus, incentive pay, equity, and benefits may be provided in addition to base compensation.
• Career growth opportunities in a growing organization.
• Collaborative, supportive cross-functional team culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Director