Cookie Notice**Title:Director, Global Regulatory AffairsCompany:Ipsen Innovation (SAS)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 and follow our latest news on and .Job Description:WHAT - Summary & Purpose of the PositionThe Director of Global Regulatory Affairs is responsible for developing and implementing regulatory strategies for assigned programs, both regionally and globally. This role provides regulatory expertise to R&D, Franchise, and Commercial Operations, acting as the liaison between these teams and Global Regulatory Affairs (GRA) on all regulatory matters. The director ensures the seamless execution of regulatory strategies for both development and marketed products, oversees regulatory intelligence for relevant disease areas, and communicates the implications of emerging trends. Additionally, the role involves participating in external influencing activities with health authorities or trade associations and leading operational excellence initiatives within GRA.WHAT - Main Responsibilities & Technical Competencies Accountable for the development, flawless execution and implementation of regulatory strategies 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: + Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs within the assigned portfolio, 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; proposes remediation where possible. + With R&D, Franchise, Operations and Asset Team/Sub-teams, define appropriate strategy in terms of sequencing of 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. + 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). + Advocates to and seeks buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies + Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making. + 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. + Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues. + Review and input on all key documentation relevant to Franchise plans as required. + Responsible for conducting regulatory due diligence assessment on external opportunities. + Lead operational excellence initiatives within GRA Regulatory Intelligence: + Accountable for continuously monitoring the scientific evolution of the assigned diseases within the therapeutic area for its regulatory impact; incorporates external environment into plans. + Accountable for collecting, recording and sharing of competitive regulatory information for Ipsen competitor products for the assigned disease areas within the therapeutic area. + Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way + Responsible for promoting activities and processes to reinforce "good external influencing behaviors" in the GRA organization Additional Responsibilities: + Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. + Ensures timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). + Contribute towards effective planning of the GRA budget. + Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policiesKnowledge & Experience (essential): 10+ years in Regulatory affairs with significant experience in the pharmaceutical industry. Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Proven experience of US BLA/NDA or sBLA/NDA submission Track record of building excellent relationships with regulatory authorities FDA. Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles. Ability to distil key information from complex and extensive sources and present the information in a constructive way.* Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects.* Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.* Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally.* Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing
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