Regulatory Operations Director

4 weeks ago

Cambridge, Massachusetts, United States Ipsen Pharma Full time
Job Title: Director, Regulatory Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: As a key member of the US Regulatory and Quality leadership team, the Director of Regulatory Operations will be responsible for formulating and implementing operational management strategies to create a best-in-class US regulatory operations team. This role will also provide technology leadership and ownership of Ipsen's Advertising/Promotion and Labeling submissions, as well as associated tools. Main Responsibilities: * Serve as a strategic thought partner to the VP US Regulatory and Quality on complex problems, current and future initiatives, organization, strategies, and budgets. * Provide guidance and influence the departmental operation and future vision as a member of the US Regulatory and Quality leadership team. * Identify synergies and interdependencies across teams to ensure an optimal working model. * Monitor PRC KPIs and provide support to Coordinators to ensure they remain on track, providing insight for future planning. * Establish meaningful KPIs and MRC calendars to enable better resource planning. * Expertly apply current and new technologies within the US Ad/Promo/Labeling function to 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, leading associated validation requirements. * Evaluate new tools and potential AI applications to lead to greater efficiencies. * Provide expertise in efficiencies and process mapping to guide scaling decisions. * Collaborate cross-departmentally and within the US organization on Design Space vs. PRC (regulated space) with our franchises and internal stakeholders. * Prepare monthly dashboard updates. * Maintain PRC SharePoint site. * Partner with PRC teams to own copy editing, QC, submission prep for SubPart H and 2253, materials for FDA, maintaining high-quality submission standards. * Own US SPL submissions and maintenance. * Attend PRC meetings to gain insight into products and materials for future submissions. * Partner within US RA and QA, Global RA, and our cross-functional US stakeholders. * Own the submission process to FDA for SPLs (labeling) and ad promo, ensuring eSub standards are met. * Partner with Coordinators and Reviewers on establishing/editing local SOPs, work instructions, and guides. * Lead 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. Requirements: * B.A./B.S. degree in life sciences or technical writing. * 15+ years of direct regulatory experience in a biotechnology environment. * 3+ years of management experience. * Excellent working knowledge of FDA regulations and ICH guidelines. * Excellent written and interpersonal communication skills. * Ability to lead and work with others in a positive and collaborative manner. * 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. * Cultivates relationships throughout Ipsen. * Proficient experience with submission publishing software and tools, Veeva PromoDocs. * Proficient use of MS Office and Adobe suites. Key Technical Competencies: * Excellent written and oral communication skills and delivers all communication with clarity and impact. * Strong organizational and project management skills. * Shows a constant focus on improving performance and excellence in all tasks. * Ability to influence and interact effectively across relevant functions internally and externally. * Consistent ability to foster strong matrix working. * Be an innovator of new ideas and best practices. * Must anticipate and solve problems. * Recognized as a leader, team player, and possess a cross-functional collaborative skill set. * Ability to manage multiple activities or projects. * Excellent interpersonal and negotiation skills with an ability to build networks within Ipsen and use them to secure appropriate support and outcome for a project. * Highly proficient in FDA electronic submission standards. * Highly proficient in regulatory technologies. Benefits: This job is eligible to participate in our short-term incentives program as well as our long-term incentives program. At Ipsen, we are 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. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. Pay Range: The annual base salary range for this position is $177,000-$259,600.

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