Senior Manager, Regulatory Affairs - Biologics

Vericel; Burlington (MA); Hybrid; USD 80,000 - 130,000; Full time

Job summary

An established industry player in regenerative medicine is seeking a Senior Manager of Regulatory Affairs to lead regulatory projects and submissions. This role is pivotal in ensuring compliance with FDA regulations and advancing innovative treatments that transform patient care. The ideal candidate will possess extensive experience in biologics and regulatory affairs, demonstrating strong writing and communication skills. Join a collaborative team that values growth and innovation, and be part of a mission that significantly impacts patient lives. This position offers a hybrid work schedule, combining in-office collaboration with remote flexibility, fostering an engaging work environment.

Benefits

Career Growth Opportunities

Collaborative Culture

Cutting-Edge Science

Qualifications

• 5-7 years of direct Regulatory Affairs experience with biologics.
• Strong regulatory writing and verbal communication skills required.

Responsibilities

• Manage regulatory activities for development projects with minimal supervision.
• Ensure compliance of regulatory submissions with requirements.

Skills

Regulatory Affairs

Regulatory Writing

Communication Skills

Attention to Detail

Team Collaboration

Education

Bachelor of Science in a Scientific Discipline

Advanced Degree

Tools

eCTD

FDA Regulations

Job description

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 Senior Manager, Regulatory Affairs - Biologics manages, evaluates and completes regulatory projects consistent with the company goals. This individual is responsible for timely planning and coordination of regulatory submissions and will provide guidance to cross-functional teams on regulatory strategy and tactics. This individual keeps abreast of regulatory procedures and practices. The Senior Manager will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

Schedule:

As a company that thrives on teamwork and face-to-face collaboration, Vericel follows a hybrid schedule with in-office days Monday - Thursday in our new Burlington, MA location, and flexibility to work remotely on Fridays.

Position Scope:

1. With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
2. Manage the assembly and timely submission of applications (i.e., INDs, BLAs and other dossiers) as required for investigation and registration of biologics.
3. Ensure regulatory submissions are maintained in compliance with regulatory requirements.
4. Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
5. Participate on project teams and provide expertise on regulatory matters related to biologics.
6. Develop and maintain current regulatory knowledge and advise management of significant developments.
7. Contribute to internal improvements related to best practices and SOPs.
8. Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.

Qualifications:

1. Bachelor of Science in a scientific discipline; advanced degree (preferred).
2. 5-7 years direct Regulatory Affairs experience with biologics.
3. Previous experience with combination products and/or botanicals a plus.
4. Experience and knowledge in preparation of BLA submissions and supportive amendments and supplements.
5. Experience with prescription drug advertising regulations and promotional review committee.
6. Experience with labeling regulations.
7. Working knowledge of FDA regulations and understanding of FDA structure and function.
8. Working knowledge of eCTD elements and structure.
9. Strong regulatory writing skills and verbal communication skills.
10. Strong team player that has a customer service approach and is solution oriented.
11. Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.

Why Vericel?

1. Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
2. Career Growth: Be a part of a growing organization with opportunities to expand your impact.
3. 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.