Regulatory CMC Director — Global Submissions (Hybrid)

Xenon Pharmaceuticals Inc.; Needham (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Xenon Pharmaceuticals Inc. is seeking a senior regulatory affairs CMC leader to supervise regulatory activities for major development and commercial assets.

This role requires driving global CMC submissions, coordinating with cross-functional teams across regulatory, quality, and supply to ensure readiness for marketing applications and variations. The ideal candidate will have 12+ years in Regulatory Affairs with track records across US, EU, and Canada, and strong communication skills.

Qualifications

• Bachelor’s/Master’s/PhD in scientific, medical, or regulatory field with 12+ years in Regulatory Affairs, incl. late-stage development and/or commercial products.
• Experience managing commercial programs in US, EU, Canada, and other major markets.
• Hands-on submissions experience: INDs/CTAs and/or marketing applications, supplements, variations.
• Track record of successful global regulatory submissions and strategies.
• Prior liaison with Regulatory Agencies is desirable.

Responsibilities

• Provide strategic regulatory CMC leadership for major development or commercial assets and advise cross-functional teams.
• Communicate regulatory risks and mitigations promptly to teams and stakeholders.
• Manage reporting requirements, including annual and periodic reports.
• Lead preparation and alignment of CMC sections for regulatory submissions (marketing applications, supplements, variations).
• Collaborate with CMC, Operations, Quality, Supply Chain, and Program Management to ensure regulatory readiness; work with Technical Writers for accurate CMC submissions.
• Lead multidisciplinary teams preparing responses to Regulatory Agency questions.
• Plan and conduct meetings with global regulatory agencies to align CMC strategies and resolve issues for late-stage or commercial programs.
• Support quality systems (change control, deviation, inspection management) and assess manufacturing changes for regulatory impact.
• Contribute to departmental objectives and continuous improvement in Regulatory Affairs CMC.
• Interpret emerging global regulatory requirements and advise on impact to development and commercial programs.
• Aid in recruitment, coaching, and evaluation of direct reports as applicable.
• Ensure adherence to Company policies and code of conduct; travel as required.
• Other duties as assigned.

Skills

Regulatory CMC leadership

Global regulatory submissions

Stakeholder management

MS Office suite (Excel, PowerPoint, PM

Veeva RIM (desirable)

Education

Bachelor/Master/PhD in science/regulatory

Tools

Veeva RIM

Microsoft Office

Job description

Xenon Pharmaceuticals Inc. is seeking a senior regulatory affairs CMC leader to supervise regulatory activities for major development and commercial assets.

This role requires driving global CMC submissions, coordinating with cross-functional teams across regulatory, quality, and supply to ensure readiness for marketing applications and variations. The ideal candidate will have 12+ years in Regulatory Affairs with track records across US, EU, and Canada, and strong communication skills.