Senior Manager, Regulatory Affairs (Clinical)

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 azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b “X-TOLE” study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our 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 a Senior Manager, Regulatory Affairs to join our team. This role will develop, propose and implement well-informed global regulatory strategies within a highly cross-functional, collaborative, project team environment. The Senior Manager will provide regulatory support for clinical studies (as assigned) with the objective to obtain regulatory approvals for the initiation of clinical studies, as well as any amendments and maintenance activities for the continued conduct of clinical studies.
The ideal candidate will be an independent and self-directed team player with strong communication and influencing skills. This individual will also be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research organizations (CROs), and other vendors as required.
This position reports to the Director, Regulatory Affairs and will be ideally located in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates.
RESPONSIBILITIES:
• Actively participate as a member of the Regulatory Affairs team on multidisciplinary project/clinical study teams by providing input on study documentation and procedural requirements as defined by regulatory authorities including: regulatory submission strategy, reviewing of documents and analysis of procedures used during clinical development.
• Lead some aspects of regulatory strategy and support others depending on complexity.
• Work with business partners, external experts, CROs and internal colleagues, to align on global regulatory strategy and coordinate regulatory submissions.
• Author, review, contribute and edit submissions to support clinical development including US Investigational New Drug (IND) submissions, Canadian and/or EU Clinical Trial Applications (CTAs), New Drug Application (NDA) and other global submission documents in conformance with regulatory requirements and strategies to ensure high quality and timely submissions.
• Support multidisciplinary team in preparing responses to regulatory agency questions during the IND and CTA review phases for assigned projects.
• Provide support to prepare project teams for FDA and other regulatory agency meetings, as required.
• Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
• Maintain knowledge of global competitive landscape, regulatory environment, regulatory agency regulations and guidelines, providing interpretation to internal stakeholders and initiating process improvements as appropriate.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed.
• Occasionally travel internationally for meetings and conferences may be required.
• Other duties as assigned.
QUALIFICATIONS:
• A Bachelor’s, or Master’s, PharmD or PhD in a scientific, medical or regulatory discipline with a minimum of 6 years Regulatory Affairs management experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment required.
• E