The Senior Project Manager, Regulatory Operations will establish the infrastructure for the operational management of all product licenses (biologics and devices) documentation and will be responsible for regulatory tracking activities, including submission planning, tracking of commitment dates and submission management. The person in this position will oversee the documentation and submission management processes at Vericel, managing internal and external resources to ensure that the central depository of regulatory documents and regulatory submissions are compliant with FDA guidelines and other applicable regulatory requirements, which may include those of international regulatory authorities. This position will be responsible for the management of early development, registration and life-cycle management projects.
- Oversee and maintain the structure of the Regulatory Document Management System to ensure adequate storage, security, and retrieval of regulatory documents (paper or electronic).
- Ensure FDA requirements for regulatory document retention are met.
- Work with internal and/or external resources to develop/implement a searchable regulatory database that will allow retrieval of regulatory documents and templates. Manage all regulatory document database(s).
- Work with internal and/or external resources to implement a submission management system that will allow document authoring, version control, and links to other document management system for the preparation of eCTD submission.
- Work effectively and provide regulatory submission expertise to cross-functional teams.
- Oversees the publishing and electronic submission to FDA and other regulatory agencies.
- Project manage the planning, tracking and preparation of regulatory compliant, submissions to achieve FDA and Corporate timelines.
- Works effectively with cross-functional teams in the planning, tracking and preparation of regulatory submission.
- Presents project plans to senior management and alerts in regards to project delays or regulatory risks to timelines of regulatory commitments.
- Contribute to the development of regulatory processes and procedures to support functional area growth.
- Lead and develop internal regulatory operations staff and manage external vendor relationship.
Qualifications, Education and Experience
- Bachelor’s degree required (scientific discipline preferred).
- 3-5+ years pharmaceutical or biotech industry experience in regulatory document and/or project management.
- Regulatory experience working with a commercial stage product desired.
- Experience in eCTD submissions and working knowledge of US and international drug guidelines and regulations related to regulatory operations.
- Extensive experience with Microsoft software, Adobe Acrobat and electronic publishing software desirable.
- 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.
All qualified 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 Employer.