Senior Director, Regulatory Affairs, CMC

Xenon Pharmaceuticals•Needham, MA

1d•$260,000 - $298,700•Hybrid

About The Position

Xenon Pharmaceuticals is seeking a Senior Director, Regulatory Affairs, CMC. The position reports to the Executive Director, Regulatory Affairs, CMC, and 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. The position level will be commensurate with the candidate’s education and industry experience. The successful candidate will provide strategic regulatory CMC leadership for major development or commercial assets and advise cross-functional teams. They will lead the planning, preparation, review, and submission of high-quality CMC sections for regulatory filings, work with internal partners to advance programs and maintain regulatory readiness, and lead responses to regulatory agency questions. The role also supports agency interactions, quality systems, manufacturing change assessments, interpretation of global requirements, and departmental improvement initiatives. 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 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 one or more 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, review, and obtain stakeholder alignment on CMC sections of regulatory submissions for 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 sections of regulatory submissions 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 and regulatory applications, supplements, and variations.
Provide regulatory support for quality systems such as 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 advise on potential impacts to development and commercial programs.
Assist with recruitment and, if applicable, direct, develop, coach, and evaluate direct reports in accordance with company HR policies and practices.
Act in accordance with company policies, including the Code of Business Conduct and Ethics, and ensure policies are understood and followed by any direct reports.
Perform other duties as assigned.
Travel as required.