Senior Director, Regulatory Affairs, CMC

Xenon Pharmaceuticals•Needham, MA

1d•Hybrid

About The Position

Xenon Pharmaceuticals is seeking a Senior Director, Regulatory Affairs, CMC, to provide strategic regulatory CMC leadership for one or more major development or commercial assets and advise cross-functional teams. The role reports to the Executive Director, Regulatory Affairs, CMC. It is based in the company's Needham office in Boston, Massachusetts; remote locations may be considered for exceptional candidates. Hybrid positions require at least two onsite days per week. Position level will be commensurate with the candidate’s education and industry experience. Some travel may be required.

Requirements

Bachelor’s, Master’s, or PhD in a scientific, medical, or regulatory discipline.
12+ years of progressively responsible Regulatory Affairs experience in the pharmaceutical or biotechnology industry, including significant Regulatory CMC experience supporting late-stage development and/or commercial products.
Experience managing commercial programs marketed in the US, EU, Canada, and other major markets.
Hands-on experience managing and preparing regulatory submissions, including INDs/CTAs and/or marketing applications, supplements, and variations in the US and other major markets.
Demonstrated track record of successful global regulatory submissions and strategies.
Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
Detail-oriented, with excellent written and verbal communication and presentation skills.
Ability to work independently and collaboratively, with a high degree of flexibility in a fast-paced team environment involving internal and external team members.
Proficiency with Microsoft Excel, PowerPoint, Project, and Word.

Nice To Haves

Prior Regulatory Agency liaison experience.
Experience with Veeva RIM.

Responsibilities

Provide strategic regulatory CMC leadership for major development or commercial assets and serve as a senior regulatory CMC advisor to cross-functional teams.
Communicate risks and potential mitigations to teams and key stakeholders in a timely manner.
Manage and ensure compliance with reporting requirements, including annual and periodic reports.
Plan, manage, author, and review CMC sections of regulatory submissions, and obtain stakeholder alignment to support marketing applications, supplements, and variations.
Partner with CMC, Operations, Quality, Supply Chain, and Program Management to advance programs and ensure regulatory readiness.
Work with Technical Writers to ensure CMC submission sections are accurate and compliant.
Lead multidisciplinary teams preparing responses to Regulatory Agency questions.
Plan, organize, and contribute to formal meetings with global regulatory agencies to align on CMC strategies, resolve CMC issues, and oversee proactive interactions for late-stage or commercial programs, marketing registration applications, supplements, and variations.
Provide regulatory support for relevant quality systems, including change control, deviation, and inspection management.
Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation.
Contribute to departmental objectives and continuous improvement initiatives within Regulatory Affairs CMC.
Interpret emerging global regulatory requirements and provide strategic guidance on their potential impact on development and commercial programs.
Recruit, direct, develop, coach, and evaluate direct reports, if any, in accordance with company Human Resource policies and practices.
Act in accordance with company policies, including the Code of Business Conduct and Ethics, and ensure that direct reports, if any, understand and follow policies.
Perform other duties as assigned.