Senior Director, CMC Regulatory Strategy

Xenon Pharmaceuticals; Boston (MA); Presencial; USD 190.000 - 270.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Stock options

Tuition assistance

Descripción de la vacante

Xenon Pharmaceuticals seeks a Senior Regulatory Affairs CMC Leader based in Boston, MA, with 12+ years in regulatory affairs and strong CMC experience. The role leads global regulatory strategies and aligns cross-functional teams to advance major assets through submissions.

The position offers a hybrid model with two onsite days per week, competitive compensation, and comprehensive benefits. You will influence regulatory readiness across late-stage programs and commercial considerations.

Formación

• Bachelor’s/Master’s/PhD in a scientific or regulatory discipline.
• 12+ years of regulatory affairs experience, with CMC focus.
• Experience managing global regulatory submissions (INDs/CTAs, marketing applications).
• Track record of successful global regulatory submissions and strategies.

Responsabilidades

• Provide strategic regulatory CMC leadership for major assets and act as senior advisor to cross-functional teams.
• Communicate risks and mitigations to teams and stakeholders in a timely manner.
• Manage reporting requirements including annual and periodic reports.
• Plan, author, review, and obtain alignment for CMC sections of regulatory submissions.
• Partner with CMC, Operations, Quality, Supply Chain, and Program Management to advance programs.

Conocimientos

Regulatory CMC leadership

Cross-functional leadership

Regulatory submissions

Global regulatory strategy

Budget and project management

Educación

Bachelor’s/Master’s/PhD in regulatory or scientific discipline

Descripción del empleo

Xenon Pharmaceuticals seeks a Senior Regulatory Affairs CMC Leader based in Boston, MA, with 12+ years in regulatory affairs and strong CMC experience. The role leads global regulatory strategies and aligns cross-functional teams to advance major assets through submissions.

The position offers a hybrid model with two onsite days per week, competitive compensation, and comprehensive benefits. You will influence regulatory readiness across late-stage programs and commercial considerations.