Senior Manager, Regulatory Affairs, Operations
Xenon Pharmaceuticals Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $146,800 - $185,700 per year
Job Level
About the role
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory Information Management (RIM)Submission managementeCTDLifecycle managementMetadata governanceData governanceDocument formattingRegulatory submissionsSOP developmentDocument templates
Soft Skills
Strong initiativeDriveInterpersonal skillsCommunication skillsCross-functional teamwork