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Senior Manager, Regulatory Affairs, Operations - Boston Massachusetts
Company: Xenon Pharmaceuticals Inc.
Location: Boston, Massachusetts
Posted On: 05/01/2025
Senior Manager, Regulatory Affairs, OperationsBoston, MA, USA Req #342Thursday, February 20, 2025Who 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, Operations to join our team. The ideal candidate is 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. This role will manage regulatory submissions, publishing activities, and submission archiving. This individual will have a strong understanding of FDA/EMA regulations and experience with life cycle management of regulatory submissions such as INDs, international clinical trial applications (CTAs), or marketing applications in electronic Common Technical Document (eCTD) format. It is essential the individual has excellent written and effective verbal communication skills, proficiency in project management, and is flexible and adaptable to working in a fast-paced and complex environment.This position reports to the Director, Regulatory Affairs, Operations 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 candidate's education and industry experience. For Boston-based candidates, this role is a hybrid position, requiring a minimum of 2 days per week in the office.RESPONSIBILITIES: - Maintain processes for regulatory submission document formatting, working with external publishing vendors, and transmittal to regulatory agencies.
- Manage contractual relationships and workstreams with external publishing vendors for building submissions in the eCTD structure and filing the output via the Electronic Submissions Gateway (ESG).
- Serve as the unblinded regulatory person for the sign-off (Covering Letter/FDA form 1571) and manage the submission of expedited safety reports (i.e., SUSARs) to the FDA. In addition, performing periodic review of safety submission trackers for submission compliance with regulatory timeline requirements.
- Support regulatory program leads and project teams in creating timelines for activities related to the preparation and publishing of regulatory submissions.
- Maintain the Xenon regulatory submission calendar and other internal trackers, provide status updates, and ensure that stakeholders have the most recent versions for their reference.
- Provide advice from an operation's perspective across all projects on the acceptability of regulatory submission and publishing timelines in regard to coordination of internal and external resources and vendors.
- Contribute to internal process improvements that impact Regulatory department operational functions.
- Communicate current and emerging publishing and routine reporting regulatory requirements to stakeholder groups within Xenon.
- Advise on and direct the evaluation, selection, and implementation of technology, systems, and tools related to submission planning, publishing, assembly, and archiving.
- Contribute to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities. Consult with other groups to ensure consistency in processes and procedures for documents destined for regulatory submissions. Update internal processes to ensure compliance with health authority requirements and expectations.
- Develop and maintain document templates (e.g., eCTD content and structure per ICH guidelines) and internal style guides for documents to be submitted in regulatory filings.
- 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:
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