Manager, Regulatory

2 weeks ago

Burlington MA United States Vericel Corporation Full time

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

  • Manager, Regulatory

    4 days ago

    Burlington, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionThis 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...

  • Manager, Regulatory

    2 weeks ago

    burlington, United States Vericel® Corporation Full time

    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...

  • Manager, Regulatory

    2 weeks ago

    Burlington, United States Vericel® Corporation Full time

    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...

  • Manager, Regulatory

    3 weeks ago

    Burlington, United States Vericel® Corporation Full time

    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...

  • Manager, Regulatory

    3 weeks ago

    burlington, United States Vericel® Corporation Full time

    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...

  • Regulatory Manager

    3 weeks ago

    Waltham, MA, United States BostonGene Full time

    Position SummaryBostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular...

  • Regulatory Affairs Manager

    2 weeks ago

    Boston, MA, United States Spencer Rigby Full time

    Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...

  • Senior Manager, Regulatory Affairs

    3 weeks ago

    Boston, MA, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...

  • Manager, Accreditation

    4 weeks ago

    Cambridge, MA, United States Cambridge Health Alliance Full time

    Location: 1035 Cambridge Street Work Days: M-F with some flexibility required  Category: Professional and Management  Department: Risk Management  Job Type: Full time  Work Shift: Day Hours/Week: 40Union Name: Non UnionThe Quality and Safety Department serves as a resource center to the organization to cultivate a culture of safety, eliminate...

  • Manager, Global Regulatory Affairs CMC Submission Management

    4 weeks ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • Director, Regulatory Strategy

    2 weeks ago

    Boston, MA, United States Inozyme Pharma Full time

    Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in...

  • Account Manager

    2 weeks ago

    Washington, DC, United States Vixio Regulatory Intelligence Full time

    Account Manager - (Washington DC)Company:VIXIO is the leading provider of regulatory intelligence. Our trusted insights and analysis give our clients a true picture of what’s happening in an ever-changing landscape. We help our clients make informed strategic decisions to mitigate risks, capitalize on business opportunities and findcompetitive advantage....

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Boston, MA, United States Arevna Full time

    Overview of the Role:The Senior Regulatory Specialist provides comprehensive regulatory expertise, supporting daily departmental operations and collaborating with the Manager of Regulatory Affairs to manage global medical device registrations. This role involves ensuring the department’s compliance with regulatory policies and managing both electronic and...

  • Vice President of Quality and Regulatory Affairs

    4 weeks ago

    , MA, United States Rapiscan Systems Full time

    Quality and Regulatory Affairs LeaderRapiscan Systems is a leading provider of detection technology, offering cargo and vehicle inspection systems and services for various industries. We strive to deliver best-in-class imaging, high reliability, and operator satisfaction to our customers.The Vice President of Quality and Regulatory Affairs will play a...

  • Manager of Regulatory Affairs and Compliance

    3 weeks ago

    Jacksonville, FL, United States Ascendo Resources Full time

    Position Summary: We are seeking a highly skilled and detail-oriented Manager of Regulatory Affairs and Compliance to lead and oversee the organization's regulatory activities. This position plays a critical role in ensuring that the company complies with all applicable laws, regulations, and industry standards, while also managing the development and...

  • Regulatory Affairs Program Manager

    4 days ago

    Hicksville, NY, United States Flagstar Bank Full time

    Pay Range: 200- 220K The Regulatory Affairs Program Manager is responsible for a multitude of multi-year projects and programs leading mandatory and strategic regulatory change supporting multiple lines of business. Supports the achievement of regulatory goals including the development and management of comprehensive project plans to remediate and enhance...

  • Director, Regulatory Affairs

    2 weeks ago

    Burlington, United States Vericel® Corporation Full time

    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...

  • Director, Regulatory Affairs

    2 weeks ago

    burlington, United States Vericel® Corporation Full time

    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...

  • Director, Regulatory Affairs

    2 weeks ago

    Burlington, United States Vericel® Corporation Full time

    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...

  • VP Regulatory Management, Asset Management Compliance

    24 hours ago

    Boston, MA, Suffolk County, MA; Massachusetts, United States Fidelity Investments Full time

    Vice President, Fidelity Digital Assets Compliance – Product Advisory As a leader within the Fidelity Digital Asset Services, LLC (FDAS) Compliance team, you will serve as an informed and trusted business partner, who promotes a culture of ethical conduct and dedication to compliance, regulatory and legal obligations. In this role you will lead the...