Manager, Regulatory Affairs
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy.
Xenon has a number of promising therapeutics in clinical development, valuable collaborations with pharmaceutical partners, and innovative early-stage research underway and also has a strong balance sheet to support its continued growth in 2021 and beyond.
We are a collaborative, ambitious, and driven team with a common mission to improve the lives of patients with neurological disorders. Creating a healthy and productive work environment is a priority, and we understand the importance of investing in our employees’ growth and development. We support charities and volunteerism, knowing that when our people contribute to their local communities, they are gaining new experiences and becoming even better leaders. Xenon’s employees are smart, passionate, and driven by their incredibly important work to discover, develop and deliver new medicines for patients in need. We are looking for talented and determined individuals who thrive in a fast-paced and dynamic work environment to join our team during this transformative time for the company.
We are seeking a Manager of Regulatory Affairs to join our team. This is a permanent full-time, office-based position at Xenon’s Burnaby office, or remote in Canada. The candidate should be an independent and self-directed contributor who will be responsible for supporting regulatory activities for submissions to Health Authorities around the world for Xenon’s programs. Reporting to the Senior Manager, Regulatory Affairs, the Manager, Regulatory Affairs will work closely with project team members to prepare IND/CTA regulatory submissions for the development of Xenon’s products and will be responsible for ensuring completion of all regulatory submissions relevant to assigned projects per established timelines.
- Performs and/or coordinates the writing, updating of various sections of essential regulatory submission documents including the clinical, nonclinical, CMC, and administrative sections of file dossiers. Collaborates on submission content with Medical Writing and contributing authors across functional areas to achieve clarity and regulatory compliance.
- Evaluate and review assigned regulatory files for completeness, internal consistency with other documents, and conformance to applicable Health Authority regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compile high quality submissions that meet applicable regulatory requirements.
- Prepare regulatory submissions (electronic and paper) in coordination with Xenon’s eCTD vendor of Investigational New Drug and Clinical Trial Applications, SUSAR reports, annual reports, and other routine amendments.
- Manage the regulatory files for the assigned Xenon projects including submissions and approvals, meeting requests and responses/minutes, and correspondence.
- Track regulatory reporting requirements for the assigned Xenon projects in the applicable jurisdictions, ensuring that the Clinical Development Team is provided with adequate notice to prepare/review annual reports, etc.
- Provide regulatory input and advice on the creation, implementation, and revision of SOPs.
- Keep up-to-date with current regulatory environments in North America, Europe, and other applicable markets.
- Establish and maintain effective cross-functional team communications, advise on strategy and implementation of quality principles as well as regulatory requirements while remaining independent.
- Actively participates in all aspects of project development, including the review of clinical trial protocols, consent forms, applicable study plans, and other essential regulatory documents as a member of the clinical study team.
- Perform other duties as assigned.
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s 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.
- Bachelor’s degree from an accredited institution in a scientific or health field with a minimum of 5 years of direct, relevant Regulatory Affairs experience in the pharmaceutical or biotechnology industry with a focus on clinical and nonclinical regulatory aspects. International regulatory experience preferred.
- Regulatory Affairs degree or certification a plus.
- Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution.
- Knowledge of Canadian, US, and/or European/International regulations and standards; previous experience with IND and CTA submissions preferred.
- A good understanding of all phases of the drug development process and the interdependencies between regulatory and other functional areas.
- Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external stakeholders.
- Demonstrates proficiency in negotiation and conflict resolution.
- Able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities.