This role will be based full time in our new, state of the art facility located in Burlington, MA. There may be times that a visit to our current Cambridge location will be necessary.
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Regulatory Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Manager of Regulatory is responsible for supporting key functions within the Regulatory team and across the Vericel organization. This includes the planning, submission management, and submission of regulatory applications, reports, and other documents required for product approvals and maintaining a compliant US License Marketing Authorization for biologics and devices products. This individual will lead initiatives for optimizing processes, systems, and tools to improve the speed and cost-effectiveness of regulatory operations while maintaining data integrity and quality.
DUTIES AND RESPONSIBILITIES
- Manage the planning, assembly, tracking and preparation of technically compliant submissions to achieve FDA and Corporate timelines.
- Ensure FDA requirements for regulatory document retention are met.
- Oversee publishing and electronic submissions to FDA and other regulatory agencies.
- Maintain effective partnerships with vendors and/or IT business partners.
- Maintain the structure of RIM system’s to ensure adequate storage, security, and retrieval of regulatory documents.
- Collaborate cross functionally on technology initiatives, such as implementing new systems or upgrades and contribute to the development of regulatory processes, procedures, and systems.
- With supervision, plan and manage regulatory activities related to assigned development projects.
- Develop and maintain current regulatory knowledge and advise management of significant developments.
- Contribute to improvements in department best practices and SOPs.
- Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- Bachelor’s Degree required; Advanced degree (or progress towards one) is desired but not preferred.
- 3-5 years of Regulatory or related roles required.
- Working knowledge of drug laws, regulations and guidelines is essential.
- A solid understanding and expertise in submission and project management.
- Demonstrated ability to organize, prioritize, and execute projects to completion.
- Excellent technical understanding and proven, hands-on experience in technologies such as: SharePoint, eCTD Publishing Tools, Veeva, Smartsheet, DocShifter, Adobe, Authoring Templates and Microsoft Office.
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
