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Director, Regulatory Operations

1 month 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 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 Executive Director, Regulatory Affairs 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 Operations will manage the operational infrastructure and processes for Vericel products (biologics, drugs and devices). The Director will be responsible for the management of regulatory tracking activities which includes, but is not limited to, submission planning, commitment dates and submission management. This individual will guide the future direction of regulatory technology, systems and associated tools that support Regulatory Affairs. The Director will oversee the documentation and submission management processes at Vericel, managing internal and external resources to ensure compliance with FDA guidelines and other applicable regulatory requirements, which may include those of international regulatory authorities. The individual will report to the Executive Director, Regulatory Affairs and have one direct report.


ESSENTIAL FUNCTIONS

  • Oversee and maintain the structure of the RIM system to ensure adequate storage, security, and retrieval of regulatory documents.
  • Ensure FDA requirements for regulatory document retention are met.
  • Work with internal and/or external resources to manage the submission management processes that will allow document authoring, version control, and links to other documents.
  • Oversee the publishing and electronic submission to FDA and other regulatory agencies.
  • Project manage the planning, tracking and preparation of technically compliant submissions to achieve FDA and Corporate timelines.
  • Work effectively with cross-functional teams in the planning, tracking and preparation of regulatory submissions.
  • Contribute to the development of regulatory processes, procedures, and systems to support functional area growth.
  • Work closely with IT business partners on all aspects of regulatory system management.
  • Lead and develop internal regulatory operations staff and manage external vendor relationships.


QUALIFICATIONS, EDUCATION AND EXPERIENCE

  • Bachelor's degree (Scientific discipline preferred)
  • Advanced degree (preferred)
  • 10+ years pharmaceutical or biotech industry experience in Regulatory Operations and/or Project Management
  • 8+ years direct Regulatory Operations experience
  • Experience in eCTD submissions and working knowledge of US and international biologics, drug and device guidelines and regulations related to regulatory operations required.
  • Experience and knowledge in preparation of 510K’s, BLAs, INDs and supportive amendments and supplements.
  • Experience with device submissions, including humanitarian devices.
  • Extensive experience with Microsoft software, authoring templates (ex. StartingPoint), Adobe Acrobat and associated plug-ins required.
  • Strong technical and troubleshooting abilities required.
  • Ability to effectively communicate operational strategy, risk, and methods to interdisciplinary teams.
  • Excellent project management, organizational and communication skills.
  • Ability to work independently as well as part of a team environment.
  • Proven ability to manage multiple projects, identify and resolve regulatory issues.
  • Strong interpersonal skills and the ability to effectively work with others.


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.