Senior Manager, Regulatory Affairs, Operations

Xenon Pharmaceuticals Inc.

Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross-functional teams in a neuroscience-focused biopharmaceutical environment.

Posted 4/16/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $146,800 - $185,700 per yearWebsite

About the role

Key responsibilities & impact

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
Manage contractual relationships and workstreams with external publishing vendors
Serve as the unblinded regulatory person for the sign-off
Manage the submission of expedited safety reports (i.e., SUSARs)
Support regulatory program leads and project teams in creating timelines
Maintain the Xenon regulatory submission calendar and trackers
Provide advice from an operation’s perspective
Communicate current and emerging publishing and reporting regulatory requirements
Advise on and direct the evaluation, selection, and implementation of technology
Contributes to the development of SOPs, Work Instructions and training materials
Develop and maintain document templates
Act in accordance with Company policies
Some international travel may be required
Other duties as assigned

Requirements

What you’ll need

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)
A minimum of 5 years’ management level experience in a pharma or biotech environment
Experience with pharmaceutical regulatory submissions (specifically, eCTD)
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
Demonstrate strong initiative and drive
Ability to work successfully in cross-functional teams
Strong interpersonal and communication skills

Benefits

Comp & perks

medical
dental
vision
short-& long-term disability
accidental death & dismemberment
life insurance programs
Employee Assistance Program
travel insurance
retirement savings programs with company matching contributions
vacation
personal days
sick days
end-of-year company shutdown
expanding Training, Learning & Development program
Tuition Assistance program for advanced degrees

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory Information Management (RIM)Submission managementeCTDLifecycle managementMetadata governanceData governanceDocument formattingRegulatory submissionsSOP developmentDocument templates

Soft Skills

Strong initiativeDriveInterpersonal skillsCommunication skillsCross-functional teamwork