Senior Manager, Regulatory Affairs, Operations

Xenon Pharmaceuticals•Needham, MA

6d•Hybrid

About The Position

The Senior Manager, Regulatory Affairs Operations is instrumental in supporting global regulatory submissions across Xenon’s development portfolio. This role is responsible for submission operations, publishing strategy, and lifecycle management, partnering closely with Regulatory Program Leads and cross-functional teams to ensure timely, compliant global filings. The position operates in a fast‑paced environment and requires strong operational judgment, clear written and verbal communication, and effective vendor oversight. The ideal candidate should demonstrate deep expertise in RIM systems, and a solid understanding of FDA and EMA regulatory requirements. Additionally, they should possess experience managing the lifecycle of regulatory submissions, including INDs, international clinical trial applications (CTAs), and marketing applications in eCTD format. This position reports to the Director, Regulatory Affairs, Operations, and is based out of Xenon USA’s Needham, MA, USA office. We will consider other jurisdictions for exceptional candidates. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Requirements

Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO), including experience in project coordination and document management systems and processes. A combination of degrees and experience will be considered.
A minimum of 5 years’ management level experience in a pharma or biotech environment.
Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings, such as annual reports, IND/CTA or NDA/MAA.
Understanding of the drug development process, FDA/EMA regulations and ICH guidance.
Expert proficiency in MS Word, PowerPoint, Excel, and Adobe Acrobat.
Hands-on experience in the process of generating, reviewing and formatting documentation for worldwide regulatory submissions.
Familiarity with eCTD publishing software.
Understanding of best practices for regulatory filing planning; ability to create and manage an accessible and reliable system for regulatory document retrieval and archiving.
Demonstrate strong initiative and drive.
Must be organized, highly collaborative, and able to problem-solve and anticipate departmental needs.
Ability to work successfully in cross-functional teams.
Strong interpersonal and communication skills.

Responsibilities

Regulatory Information Management (RIM) system expertise: Submission/registration management eCTD & publishing integration Lifecycle management Metadata & data governance Workflow and process configuration
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 ensuring 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 on 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.
Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities.
Consults with other groups to ensure consistency in processes and procedures for documents destined for regulatory submissions.
Updates 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