Regulatory Operations Director

3 days ago

Burlington, Massachusetts, United States Vericel Corporation Full time
Job Title: Director, Regulatory Operations

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a highly skilled Director, Regulatory Operations to join our team. This is an exciting opportunity to contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics.

Job Summary

The Director, Regulatory Operations will be responsible for managing the operational infrastructure and processes for Vericel products, including biologics, drugs, and devices. This individual will oversee the management of regulatory tracking activities, including submission planning, commitment dates, and submission management. The Director will also guide the future direction of regulatory technology, systems, and associated tools that support Regulatory Affairs.

Key Responsibilities
  • 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
  • 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.
Equal Employment Opportunity

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. 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.

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