Director, Regulatory Affairs - CMC

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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 Director, Regulatory Affairs – CMC manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of CMC regulatory submissions. Provides guidance to cross-functional teams on CMC regulatory strategy and tactics. Keeps abreast of CMC regulatory procedures and practices. The incumbent will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

DUTIES AND RESPONSIBILITIES

• Oversees, recommends and implements CMC regulatory activities in agreement with senior management and company goals.
• Develops, recommends and implements strategies for the earliest possible approvals of CMC regulatory submissions associated with assigned development projects.
• Manages and facilitates preparation of organized and scientifically valid CMC and marketing registration applications, supplements, amendments, and variations.
• Responsible for assessing change controls for regulatory impact, reviewing and approving deviations, reviewing and approving protocols, authoring and submitting post-approval supplements, etc.
• Works closely with subject matter experts within CMC operations, R&D and QA to strengthen internal capability.
• Ensures regulatory submissions are maintained in compliance with regulatory requirements in close partnership with internal stakeholders and external partners.
• Represents the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Build / maintain relationships cross-functionally to ensure effective communication & efficient implementation of regulatory activities.
• Participate on project teams and provide expertise on CMC regulatory matters.
• 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

WORKING CONDITIONS AND PHYSICAL DEMANDS

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.

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