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Associate Director/Director, Regulatory Affairs
4 months ago
Friday, March 8, 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 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 Associate Director/Director, Regulatory Affairs to join our team. This role will develop, propose and implement well-informed global regulatory strategies in a highly cross-functional, collaborative, project team environment. The Associate Director/Director will be the regulatory lead 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 position will report to the Senior Director, Regulatory Affairs and will be in Vancouver, BC, Canada.
RESPONSIBILITIES:
- As Regulatory lead on multidisciplinary project/clinical study teams, provide input on the documentation and procedural requirements as defined by Regulatory Authorities including: submission delivery strategy, reviewing of documents and analysis of procedures used during development.
- Work with business partners, external experts, CRO’s and internal colleagues, to coordinate regulatory submissions.
- Create, review, contribute and edit submissions to support development including US Investigational New Drug (IND) submissions, Canadian and/or EU Clinical Trial Applications (CTAs).
- Lead multidisciplinary team when preparing responses to Regulatory Agency questions during the IND and CTA review phases for assigned projects.
- Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
- Provide interpretation of regulatory agencies’ feedback, policies and guidelines to internal colleagues.
- Keep up-to-date on current regulations and guidance; interpret and notify appropriate colleagues and stakeholders as appropriate.
- Develop, review, and maintain Regulatory and other company-wide and departmental policies and SOPs.
- Occasionally travel internationally for meetings and conferences.
- Other duties as assigned.
- 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.
- As Regulatory lead on multidisciplinary project/clinical study teams, provide input on the documentation and procedural requirements as defined by Regulatory Authorities including: submission delivery strategy, reviewing of documents and analysis of procedures used during development.
- Work with business partners, external experts, CRO’s and internal colleagues, to coordinate regulatory submissions.
- Create, review, contribute and edit submissions to support development including US Investigational New Drug (IND) submissions, Canadian and/or EU Clinical Trial Applications (CTAs).
- Lead multidisciplinary team when preparing responses to Regulatory Agency questions during the IND and CTA review phases for assigned projects.
- Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
- Provide interpretation of regulatory agencies’ feedback, policies and guidelines to internal colleagues.
- Keep up-to-date on current regulations and guidance; interpret and notify appropriate colleagues and stakeholders as appropriate.
- Develop, review, and maintain Regulatory and other company-wide and departmental policies and SOPs.
- Occasionally travel internationally for meetings and conferences.
- Other duties as assigned.
- 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.
A Bachelor’s, Master’s or PhD in a scientific or medical discipline with a minimum of 5 years in Regulatory Affairs in a pharmaceutical, biotechnology, contract research organization (CRO) or related industry is required.
Special knowledge, skills and/or licenses or certificates preferred, such as Regulatory Affairs Certification (RAC) highly desirable.
Demonstrated, hands-on experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS).
Demonstrated track record of successful clinical trial submissions in Canada, US, and Europe required.
Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
Balance strategic thinking and strong analytical skills with the ability to effectively execute in a prioritized manner.
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.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Proficiency with Microsoft Excel, PowerPoint, Project and Word programs.
The base salary range for this role is $ 145,180 to $188,928 CAD; 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.
