Vericel Corporation
Director, Regulatory Affairs - CMC
Vericel Corporation, Burlington, Massachusetts, us, 01805
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
Bachelor of Science in a scientific discipline. Master of Science (preferred)
10+ years with direct CMC Regulatory Affairs experience in the US market.
Practical and regulatory experience in cell therapy or biologics. Previous experience with combination products and/or botanicals a plus.
Demonstrated experience with and a clear understanding of submission content and format requirements including preparation of submissions and supportive amendments and supplements.
Experience with leading submissions and approvals including Health Authority Interactions.
Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
Demonstrated success in leading complex groups to support operational goals and contribute to the development of CMC regulatory initiatives.
Working knowledge of FDA regulations and understanding of eCTD elements and structure.
Strong regulatory writing skills and use of Microsoft Word.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
Possess excellent written and verbal communication skills.
WORKING CONDITIONS AND PHYSICAL DEMANDS
Occasional travel (5-10%)
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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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
Bachelor of Science in a scientific discipline. Master of Science (preferred)
10+ years with direct CMC Regulatory Affairs experience in the US market.
Practical and regulatory experience in cell therapy or biologics. Previous experience with combination products and/or botanicals a plus.
Demonstrated experience with and a clear understanding of submission content and format requirements including preparation of submissions and supportive amendments and supplements.
Experience with leading submissions and approvals including Health Authority Interactions.
Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
Demonstrated success in leading complex groups to support operational goals and contribute to the development of CMC regulatory initiatives.
Working knowledge of FDA regulations and understanding of eCTD elements and structure.
Strong regulatory writing skills and use of Microsoft Word.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
Possess excellent written and verbal communication skills.
WORKING CONDITIONS AND PHYSICAL DEMANDS
Occasional travel (5-10%)
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.
#J-18808-Ljbffr