Senior Manager, Regulatory Affairs, Operations

About the role

The Senior Manager, Regulatory Affairs Operations supports global regulatory submissions across Xenon's development portfolio. Key responsibilities include:

• 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 (Covering Letter/FDA form 1571)
• Manage the submission of expedited safety reports (i.e., SUSARs)
• Support regulatory program leads and project teams in creating timelines for regulatory submission activities
• Provide status updates and ensure stakeholders have the most recent versions for their reference
• Contribute to internal process improvements
• Communicate regulatory requirements to stakeholder groups
• Develop and maintain document templates and internal style guides
• Ensure compliance with health authority requirements and expectations
• Consult with other groups to ensure consistent processes and procedures
• Update internal processes to ensure compliance with health authority requirements and expectations

Qualifications

• 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)
• Minimum of 5 years’ management level experience in a pharma or biotech environment
• Experience with pharmaceutical regulatory submissions (specifically, eCTD) and supporting regulatory filings
• 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, being organized, highly collaborative, and able to problem-solve and anticipate departmental needs
• Ability to work successfully in cross-functional teams and communicate effectively