Director, Regulatory Operations

Title:

Director, Regulatory Operations

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Director, US Regulatory Operations

Summary / purpose of the position

The Director of US Regulatory Operations (RegOps) is 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. In addition, this role will influence and drive US regulatory standards through enterprise-wide partnerships. The role has two major components, the responsibilities of which can be defined as follows.

A) Regulatory Informatics and Analytics: In this capacity, the individual serves as the regulatory point of contact and is accountable in partnership with Global IT and Global business system owner for the development, implementation, and governance of US regulatory system (Veeva PromoDocs), tools, and processes (subpart H, 2253, and US labeling) meeting FDA requirements. Working enterprise wide to establish and maintain long range plans for new pieces coming to PRC to enable better resource planning, identify/influence, and drive process improvements.

B) Regulatory Project Management, AdPromo/US labeling Submission and Publishing: In this capacity, the person is accountable for project management, applicable regulatory submissions; working with internal and external Subject Matter Experts (SMEs) on defined deliverables; electronic submission standards utilizing applicable FDA eSub guidances, interfacing with Ipsen’s internal publisher(s) on submission documents; establishing US facing Standard Operating Procedures (SOPs) and Work Instructions (WIS), and training cross-functionally on regulatory processes and systems as needed.

Main responsibilities / job expectations

Responsibilities will include, but are not limited to the following:

• Be a strategic thought partner to the VP US Regulatory and Quality about complex problems, current and future initiatives, organization, strategies, and budgets.
• Serves as member of the US Regulatory and Quality leadership team providing guidance and influencing the departmental operation/future vision.
• Look across teams to identify synergies and interdependencies to ensure optimal working model.
• Monitor PRC KPIs, providing support and partnering with Coordinators as necessary to ensure that remain on track. Providing insight for future planning.  Informatics: establishing meaningful KPI’s, 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.
• Provide expertise in efficiencies and in process mapping to guide scaling decisions.
• Works with VP US RA and QA on budget management.
• Collaborates cross departmentally and within US organization on Design Space vs. PRC (regulated space) with our franchises and internal stakeholders.
• Prepares monthly dashboard updates.
• Maintains PRC SharePoint site.
• Strong partner with PRC teams to own copy editing, QC, submission prep for SubPart H and 2253, materials for FDA maintaining high quality submission standards. Owns US SPL submissions and maintenance.
• Attends PRC meetings to gain insight into products and materials for future submissions.
• Strong partner within US RA and QA, Global RA, and our cross functional US stakeholders.
• Owns the submission process to FDA for SPLs (labeling) and ad promo ensuring eSub standards are met.
• Partners with coordinators and Reviewers on establishing /editing local SOPs, work instructions, and guides. Leads efforts to update/maintain current and new documents as needed based on ongoing process efficiency assessment(s).  

• Coach and mentor associates, provide work oversight, prioritize work, and manage timelines.

Knowledge, abilities & experience

Education / Certifications:

•   B.A./B.S. degree in life sciences or technical writing.

Experienc