Xenon Pharmaceuticals Inc.
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. If you want to learn more about job opportunities at Xenon, please visit www.xenon-pharma.com
We are seeking a Specialist, Regulatory Affairs to join our team. The candidate should be an independent and self-directed contributor who will be responsible for supporting regulatory submission activities to Health Authorities around the world for Xenon’s programs. The Specialist, Regulatory Affairs will be responsible for ensuring completion of regulatory submissions relevant to assigned projects per established timelines.
Reporting to the Senior Manager, Regulatory Affairs, the Specialist, Regulatory Affairs will work closely with project team members to prepare IND/CTA regulatory submissions for the development of Xenon’s products.
This is a temporary, 12-month contract position potentially leading to a permanent position. This position will be located in Vancouver, BC, Canada; remote locations in Canada or the US will be considered for an exceptional candidate.
• Review and make recommendations on relevant clinical trial documentation (e.g. cover letters, forms, labels, patient information sheets, diary cards, study plans and manuals), to ensure compliance with ICH GCP & country specific requirements.
• Assist in preparing responses to queries and requests for additional information received from regulatory authorities.
• Liaise with CROs to provide requested regulatory documents throughout the life of a study.
• Prepare and/or compile regulatory submissions (electronic and paper) in coordination with Xenon’s eCTD vendor, for IND/CTA submissions, safety reports, annual reports, and other routine amendments.
• Manage the regulatory files for all of Xenon’s products including submissions and approvals, meeting requests and responses/minutes, and correspondence.
• Track regulatory reporting requirements for all of Xenon’s products 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.
• Perform other duties as assigned.
• Bachelor’s degree from an accredited institution in a scientific or health field with a minimum of 5 years of direct, relevant Regulatory Affairs and Clinical Research experience in the pharmaceutical or biotechnology industry, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience preferred (Regulatory Affairs degree or certification a plus).
• Knowledge of Canadian, US, and European/International regulations and standards for clinical trials with previous experience with the writing/compilation and submission of IND and Clinical Trial Applications required.
• A good understanding of all phases of the drug development process and the interdependencies between regulatory and other functional areas
• Ability to work under moderate supervision
• Strong interpersonal skills and written and verbal communication skills.
• Experience with working with functional leads directly to assemble, draft and finalize regulatory submissions.
• Fluent in English (written and spoken); second language is an asset
• Strong organizational skills to manage conflicting priorities and adhere to tight timelines
• High attention to detail with accuracy and quality
• Good computer skills (e.g. Microsoft Word, Excel, Power Point, Adobe, etc.)
To apply for this position, please visit https://can59.dayforcehcm.com/CandidatePortal/en-us/xenon, select the position you are interested in, click Apply Now to create a candidate profile, and complete the job application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for an interview will be contacted.