Senior Director, Global Regulatory Affairs, Oncology

Job description

Title: Senior Director, Global Regulatory Affairs, Oncology Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing regulatory tactics to support the execution of regulatory activities across assigned region(s) or globally, while providing regulatory expertise to R&D, Franchise, and Commercial Operations for assigned products and projects and serving as the primary interface between these functions and Global Regulatory Affairs on all regulatory matters related to Development and Product Maintenance activities. The role ensures the development and flawless execution of regulatory strategies for assigned products and projects, including all components across both development and marketed products within assigned region(s) or globally, and performs Regulatory Intelligence for relevant disease areas, identifying and communicating implications of emerging trends that may impact the business. Additionally, the Senior Director maintains a broad perspective on external influencing issues, participates in external engagement activities with health authorities or trade associations where appropriate, and leads operational excellence initiatives within Global Regulatory Affairs. WHAT - Summary & Purpose of the Position The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic leadership to assigned program(s) and implementing regulatory tactics to support the execution of regulatory activities across assigned region(s) or globally, while providing regulatory expertise to R&D, Franchise, and Commercial Operations for assigned products and projects and serving as the primary interface between these functions and Global Regulatory Affairs on all regulatory matters related to Development and Product Maintenance activities. The role ensures the development and flawless execution of regulatory strategies for assigned products and projects, including all components across both development and marketed products within assigned region(s) or globally, and performs Regulatory Intelligence for relevant disease areas, identifying and communicating implications of emerging trends that may impact the business. Additionally, the Senior Director maintains a broad perspective on external influencing issues, participates in external engagement activities with health authorities or trade associations where appropriate, and leads operational excellence initiatives within Global Regulatory Affairs. WHAT - Main Responsibilities & Technical Competencies Main Responsibilities Overall Accountability: Provide regulatory strategic leadership for the assigned program(s). Be accountable for the development, flawless execution and implementation of regulatory strategic activities for the assigned programs for assigned region(s) or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products. Product/Project Leadership: Be accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member: Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics). Provide regulatory input into the Integrated Asset Strategic Plan. In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for all key markets. Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; propose remediation where possible. With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions. Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics. Be responsible for Regulatory Intelligence for relevant disease area(s), and identify and communicate the implications of upcoming trends that may impact the business Consider regulatory avenues to maximize intellectual property protection and data exclusivity. In collaboration with other functions, ensure the establishment of CCDS and required safety plans for the assigned product. Ensure regional regulatory specificities and needs are incorporated into the global plans though collaboration with local and intercontinental RA where available. Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards). Lead the preparation of submissions incl PIP, scientific advice, orphan drug designation submissions. Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies Be responsible for ensuring potential risks have been identified and mitigation options are proactively proposed for project team and senior management decision making. Be accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes. Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Be responsible for ensuring outsourced activities are delivered on time and on budget. Be responsible for identifying and alerting management regarding any service issues. Review and provide input into all key documentation relevant to Franchise plans as required. Be responsible for conducting regulatory due diligence assessment on external opportunities. Lead operational excellence initiatives within GRA. Contribute towards effective planning of the GRA budget. People Management: Support recruitment, train, develop and retain regulatory professionals within GRA; Oversee regulatory activities assigned to his/her direct reports where applicable and manage performance and all applicable processes Ethics and Compliance: Be accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies. HOW - Knowledge & Exp