Director of Regulatory Operations

3 weeks ago

Cambridge, Massachusetts, United States Ipsen Pharma Full time

Job Summary

The Director of Regulatory Operations will be responsible for formulating and implementing operational management creating a best-in-class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen's Advertising/Promotion and Labeling submissions along with associated tools.

This role will influence and drive US regulatory standards through enterprise-wide partnerships.

Key Responsibilities

  • Regulatory Informatics and Analytics:
    • Develop, implement, and govern US regulatory systems (Veeva PromoDocs), tools, and processes meeting FDA requirements.
    • Establish and maintain long-range plans for new pieces coming to PRC to enable better resource planning, identify/influence, and drive process improvements.
  • Regulatory Project Management, AdPromo/US labeling Submission and Publishing:
    • Manage project management, applicable regulatory submissions; electronic submission standards utilizing applicable FDA eSub guidances.
    • Interface with Ipsen's internal publisher(s) on submission documents; establish US-facing Standard Operating Procedures (SOPs) and Work Instructions (WIS).
    • Train cross-functionally on regulatory processes and systems as needed.
  • Informatics:
    • Establish meaningful KPIs, MRC calendars to enable better resource planning.
    • Expert in current and new technologies and their application(s) within the US Ad/Promo/Labeling function that can lead to greater efficiencies within our processes.
    • Define functional needs and partner with global IT and global business system owner on needed VEEVA PromoDocs upgrades, lead associated validation requirements.
    • Evaluate in collaboration with global IT new tools and potential AI applications leading to greater efficiencies.

Requirements

  • 15+ years of direct regulatory experience in biotechnology environment.
  • 3+ years management experience.
  • Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing.
  • Proficient experience with electronic submissions and electronic Common Technical Document (eCTD) structure with submission publishing software.
  • Experience with Electronic Data Management Systems (EDMS) and regulatory documentation archival required.
  • Proven record of implementing regulatory process transformation and organizational culture change.
  • Role models respect and inclusion, creating a culture that fosters innovation.
  • Fluent in English.

What We Offer

Ipsen Pharma is proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts.

We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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