Senior Director, Regulatory CMC – Global Submissions

Xenon Pharmaceuticals Inc.; United States; Hybrid; USD 200,000 - 280,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Retirement plan with company match

Employee Assistance Program

Tuition Assistance

Job summary

Xenon Pharmaceuticals Inc. is seeking a senior Regulatory Affairs CMC Leader based in the Boston area (Needham office with hybrid onsite days).

You will provide strategic regulatory leadership for major assets, lead global CMC submissions, and collaborate across Clinical, Regulatory, Quality, and Operations teams to ensure regulatory readiness for pivotal programs. The role requires 12+ years in Regulatory Affairs with strong CMC experience and a track record of global submissions.

Qualifications

• Bachelor’s, Master’s, or PhD in scientific, medical, or regulatory discipline with 12+ years in Regulatory Affairs.
• Experience managing commercial programs in US, EU, Canada and other major markets.
• Demonstrated, hands-on experience preparing regulatory submissions (INDs/CTAs and/or marketing applications) in US and other major markets.

Responsibilities

• Provide strategic regulatory CMC leadership for major development or commercial assets.
• Communicate risks and mitigations to cross-functional teams in a timely manner.
• Manage and ensure compliance with all reporting requirements, including annual/periodic reports.
• Plan, manage, author, review, and obtain alignment for high-quality CMC regulatory submissions.
• Partner with CMC, Operations, Quality, Supply Chain, and PMO to advance programs and ensure regulatory readiness.
• Lead multidisciplinary teams preparing responses to regulatory questions.
• Plan and contribute to meetings with global regulatory agencies for alignment on CMC strategies.
• Provide regulatory support for quality systems and process changes.
• Contribute to departmental objectives and continuous improvement in Regulatory Affairs CMC.
• Interpret emerging global regulatory requirements and advise on impact to programs.
• Aid in recruitment, coaching, and evaluation of direct reports where applicable.
• Adhere to company policies and code of conduct; travel as needed.
• Other duties as assigned.

Skills

Regulatory leadership

CMC experience

Global regulatory submissions

IND/CTA filings

Cross-functional collaboration

Excellent communication

Regulatory strategy

Project coordination

Education

Bachelor/Master/PhD in regulatory/scientific field

Tools

MS Excel

PowerPoint

MS Project

MS Word

Veeva RIM

Job description

Xenon Pharmaceuticals Inc. is seeking a senior Regulatory Affairs CMC Leader based in the Boston area (Needham office with hybrid onsite days).

You will provide strategic regulatory leadership for major assets, lead global CMC submissions, and collaborate across Clinical, Regulatory, Quality, and Operations teams to ensure regulatory readiness for pivotal programs. The role requires 12+ years in Regulatory Affairs with strong CMC experience and a track record of global submissions.