Senior Director, Regulatory CMC - Hybrid/Remote Leader

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Xenon Pharmaceuticals seeks an experienced Regulatory Affairs professional for a senior CMC-focused role based in the Boston/Needham area. The position supports major development and commercial assets with a global regulatory strategy, including interactions with agencies and cross-functional teams.

We may consider exceptional remote candidates and require at least two onsite days per week. The candidate will oversee submissions, ensure regulatory readiness, and guide teams through complex

Qualifications

• Advanced degree in a scientific, medical, or regulatory discipline.
• 12+ years in Regulatory Affairs within pharma/biotech.
• Experience managing regulatory submissions including INDs/CTAs and marketing applications.
• Proven track record of global regulatory submissions and strategies.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Excel, PowerPoint, Project, and Word; Veeva RIM desirable.

Responsibilities

• Provide strategic regulatory CMC leadership for major assets.
• Communicate risks and mitigations to cross-functional teams.
• Manage reporting requirements including annual and periodic reports.
• Prepare and obtain stakeholder alignment for CMC sections of submissions.
• Collaborate with cross-functional teams to ensure regulatory readiness.
• Lead teams preparing responses to Regulatory Agency questions.
• Engage with global agencies to align on CMC strategies.
• Support quality systems changes and regulatory guidance.
• Contribute to departmental objectives and continuous improvement.
• Aid recruitment and coaching of direct reports.
• Travel as required.

Skills

Regulatory Affairs

CMC knowledge

Regulatory submissions

Global regulations

Education

Bachelor's degree

Master's degree

PhD

Tools

Excel

PowerPoint

Word

Veeva RIM

Job description

Xenon Pharmaceuticals seeks an experienced Regulatory Affairs professional for a senior CMC-focused role based in the Boston/Needham area. The position supports major development and commercial assets with a global regulatory strategy, including interactions with agencies and cross-functional teams.

We may consider exceptional remote candidates and require at least two onsite days per week. The candidate will oversee submissions, ensure regulatory readiness, and guide teams through complex