Senior Manager, Regulatory Affairs, Operations

About the Role The Senior Manager, Regulatory Affairs Operations supports global regulatory submissions across Xenon’s development portfolio. This role handles submission operations, publishing strategy, and lifecycle management, partnering closely with Regulatory Program Leads and cross‑functional teams to ensure timely, compliant global filings. It requires strong operational judgment, clear communication, and effective vendor oversight. Location: Xenon USA’s Needham, MA office. Hybrid roles require at least two onsite days per week; on‑site positions up to five days per week. RESPONSIBILITIES Regulatory Information Management (RIM) system expertise, including 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 via the Electronic Submissions Gateway (ESG). Serve as the unblinded regulatory person for the sign‑off (Covering Letter/FDA form 1571) and manage expedited safety report submissions (e.g., SUSARs) to the FDA, including periodic review of safety submission trackers. Support regulatory program leads and project teams in creating timelines for activities related to the preparation and publishing of regulatory submissions. Maintain the regulatory submission calendar and internal trackers, provide status updates, and ensure stakeholders have the most recent versions. Provide operational advice on the acceptability of regulatory submission and publishing timelines, coordinating internal and external resources and vendors. Contribute to internal process improvements impacting regulatory operations. Communicate current and emerging publishing and routine reporting regulatory requirements to stakeholders. Advise on and direct the evaluation, selection, and implementation of technology, systems, and tools related to submission planning, publishing, assembly, and archiving. Contribute to SOPs, work instructions, and training materials for regulatory submissions, ensuring consistency across processes. Develop and maintain document templates and internal style guides per ICH guidelines. Act in accordance with Company policies, including the Code of Business Conduct and Ethics, ensuring policies are understood and followed. Travel internationally may be required. Other duties as assigned. QUALIFICATIONS Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or CRO environment, including project coordination and document management systems; combined degrees and experience may be considered. Minimum of 5 years of management‑level experience in a pharma or biotech environment. Experience with pharmaceutical regulatory submissions (eCTD) and supporting 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 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, reliable system for regulatory document retrieval and archiving. Strong initiative and drive; organized, highly collaborative, able to problem‑solve and anticipate departmental needs. Excellent interpersonal and communication skills, able to work successfully in cross‑functional teams. Benefits Our Total Rewards program includes base salary, target bonus, stock options, and a full range of benefits such as medical, dental, vision, short‑ and long‑term disability, accidental death & dismemberment, and life insurance. Additional benefits include Employee Assistance Program, travel insurance, retirement savings with company matching, vacation, personal days, sick days, and an end‑of‑year company shutdown. Xenon provides training, learning & development programs and a tuition assistance program for advanced degrees. #J-18808-Ljbffr