Regulatory Operations Manager

Regulatory Operations Manager

Position Summary:

The Manager of Regulatory Operations will oversee daily regulatory information management (RIM) and submission activities for the organization. They will serve as the primary liaison with our submission vendor. The manager will also assist with various information management system activities including administration, change control, implementations, and related activities within and adjacent to regulatory systems. Additional legacy content migration tasks as required. The incumbent will work independently with appropriate oversight. They are expected to identify and act on activities without requiring immediate direction.

Essential Functions:

  • Primarily use an advanced Regulatory Information Management (RIM) system, Veeva Vault for most activities and tasks.
  • Facilitate submission vendor activities, support submission planning and management, execute ongoing RIM optimization, and other special projects as required.
  • Organize, stage, import, index, archive, and manage submission and related regulatory documentation. Collaborate with both internal and external stakeholders to ensure on-time and compliant delivery of various submissions.
  • Create, update, and manage submission information records within the RIM system. Run/analyze reports and provide status updates during cross-functional team meetings.
  • Suggest process optimization changes, identify procedural gaps, and assist with the development of best practice documentation.
  • Occasionally use specialized Adobe Acrobat tools (TRS Toolbox) to generate and review submission-ready documents. This may also include moderate use of regulatory authoring templates (StartingPoint).
  • Operate within the new paradigm of regulatory operations leveraging strategic resourcing wherever possible.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Education:

  • Bachelor’s Degree required.
  • Advanced degree (or progress towards one) preferred.

Experience:

  • 4-6 years direct Regulatory Operations required.
  • 2+ years experience with Electronic Document/Content Management Systems (eDMS, eCMS). System management and/or administration with Veeva Vault products highly desired.
  • Good understanding of regulatory information management (RIM) and eCTD principles and practice.
  • High level of expertise in Microsoft Suite of products, Adobe Acrobat and TRS Toolbox.
  • Technical knowledge of document/report publishing, regulatory submissions, and quality control tasks.
  • Knowledge of the drug development process, eCTD/ICH requirements, and related guidance.
  • Direct experience with US regulatory applications (BLA, IND, HDE) required. Ex-US submission experience desired.
  • Very strong attention to detail.
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Excellent written and verbal communication skills.

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.

NASDAQ: VCEL

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December 10, 2019
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