Senior Regulatory CMC Director - Global Submissions Lead

Xenon Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 260,000 - 299,000; Full time

Job summary

Xenon Pharmaceuticals Inc. in Boston, MA is seeking a Senior Regulatory Affairs professional with deep CMC expertise to lead strategic regulatory activities for major development and commercial assets.

You will drive plan creation, submissions, and risk management across US, EU, and other markets with cross-functional teams. Reporting to the Executive Director, Regulatory Affairs, CMC, this role requires a track record of global regulatory submissions, strong scientific writing, excellent

Qualifications

• 12+ years in Regulatory Affairs in pharma/biotech with CMC focus.
• Experience managing submissions US, EU, Canada and other major markets.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Provide regulatory CMC leadership for major assets and align with cross-functional teams.
• Communicate risks and mitigations to teams and stakeholders timely.
• Manage reporting requirements including annual and periodic reports.
• Plan and author CMC sections for regulatory submissions.
• Collaborate with Operations, Quality, Supply Chain, and Program Management.
• Lead teams preparing responses to Regulatory Agency questions.
• Participate in meetings with global regulatory agencies for alignment.
• Support quality systems changes and regulatory guidance for global implementation.

Skills

Regulatory CMC

Global regulatory submissions

IND/CTA submissions

Communication skills

Leadership

Regulatory strategy

Education

Bachelor/Master/PhD in scientific, medical, or regulatory discipline

Tools

Microsoft Excel

PowerPoint

Microsoft Project

Word

Veeva RIM

Job description

Xenon Pharmaceuticals Inc. in Boston, MA is seeking a Senior Regulatory Affairs professional with deep CMC expertise to lead strategic regulatory activities for major development and commercial assets.

You will drive plan creation, submissions, and risk management across US, EU, and other markets with cross-functional teams. Reporting to the Executive Director, Regulatory Affairs, CMC, this role requires a track record of global regulatory submissions, strong scientific writing, excellent