Director, Regulatory Affairs - Biologics

Regulatory Regular Full-Time Burlington, MA, US

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).

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.

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.

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.

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.

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.