Associate Director/Director, Regulatory Affairs, CMC
2 weeks ago
Associate Director/Director, Regulatory Affairs, CMC Boston, MA, USA Req #249 Monday, April 1, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our XEN1101 Phase 2b X-TOLE study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures. In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 X-NOVA clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking an Associate Director/Director, Regulatory Affairs, CMC to join our growing team. This role will develop, propose, and implement well-informed global CMC regulatory strategies in a highly cross-functional, collaborative, project team environment. The ideal candidate will be an independent and self-directed team player with strong communication and influencing skills. This position reports to the Senior Director, Regulatory Affairs, CMC and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidates education and industry experience. RESPONSIBILITIES: Propose and implement global CMC regulatory strategies and provide regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management. Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner. Assess and communicate regulatory requirements to ensure all CMC activities are in compliance with applicable regulations and guidelines. Manage and ensure compliance with all reporting requirements, including annual and periodic reports. Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of high-quality CMC sections of regulatory submissions to support initial INDs/CTAs, marketing applications, supplements and variations. Lead multidisciplinary teams preparing responses to Regulatory Agency questions. Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions for initial INDs/CTAs, marketing registration applications, supplements and variations. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of regulatory applications. Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. Develop, review, and maintain Regulatory CMC departmental policies and SOPs. Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global programs. Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Companys Human Resource policies and practices Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Some international travel may be required. Other duties as assigned QUALIFICATIONS: A Bachelors, Masters, or PhD in a scientific, medical, or regulatory discipline with 8+ years of experience in a Regulatory Affairs management function in a pharmaceutical, biotechnology, or related environment required. Experience in rare disease indications and/or orphan drug development is desirable. Demonstrated, hands-on experience, managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations. Demonstrated track record of successful global regulatory submissions and strategies. Strong competency in understanding global regulatory requirements and the emerging regulatory landscape. Detail oriented with excellent written and verbal communication and presentation skills. Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members. Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs. The base salary range for this role is $160,700 to $226,900 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here . To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted. #J-18808-Ljbffr
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