Senior Director, Regulatory Affairs, CMC

This position reports to the Executive Director, Regulatory Affairs, CMC, and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations for exceptional candidates. The level of the position will be commensurate with the candidate's education and industry experience. Hybrid positions require a minimum of two onsite days per week. Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics.

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; Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner; Manage and ensure compliance with all reporting requirements, including annual and periodic reports; Plan, manage, author, review, and obtain stakeholder alignment to facilitate the submission of high-quality CMC sections of regulatory submissions to support marketing applications, supplements and variations; Partner closely with CMC, Operations, Quality, Supply Chain, and Program Management to advance programs and ensure regulatory readiness; Work closely with Technical Writers to ensure CMC sections of regulatory submissions are accurate and compliant; Lead multidisciplinary teams preparing responses to Regulatory Agency questions; Effectively plan, organize and contribute to formal meetings with global regulatory agencies to ensure alignment 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 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 objective and continuous improvement initiatives within Regulatory Affairs CMC; Interpret emerging global regulatory requirements and provide strategic guidance regarding potential impact on development and commercial programs; Aid in recruitment, 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; Some travel may be required; Other duties as assigned

Requirements

A Bachelor's, Master's, or PhD in a scientific, medical, or regulatory discipline and 12+ years of progressively responsible experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, including significant Regulatory CMC experience supporting late-stage development and/or commercial products; Experience in managing commercial programs marketed in US, EU, Canada and other major markets; Demonstrated, hands-on experience managing and preparing regulatory submissions including INDs/CTAs and/or marketing applications, supplements and variations in 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; Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs

Nice to have

Prior Regulatory Agency liaison experience; Experience with Veeva RIM

Benefits

Total Rewards program including base salary, target bonus, and stock options; Medical, dental, vision, short- and long-term disability, accidental death & dismemberment, and life insurance programs; Employee Assistance Program; Travel insurance; Retirement savings programs with company matching contributions; Vacation, personal days, sick days, and an end-of-year company shutdown; Training, Learning & Development program; Tuition Assistance program for advanced degrees