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Xenon Pharmaceuticals Inc. · 1 day ago

Director, Regulatory Affairs, CMC

Boston, MA

Full-time

Hybrid

Director/Executive

$216K/yr - $233K/yr

10+ years exp

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery and clinical development. They are seeking a Director of Regulatory Affairs, CMC to propose and implement global regulatory strategies and provide guidance to cross-functional teams throughout the product lifecycle.

BiopharmaBiotechnologyGeneticsHealth CareMedicalPharmaceutical

Growth Opportunities

Responsibilities

Propose and implement global CMC regulatory strategies and provide regulatory guidance to cross-functional teams and functional areas for assigned programs from the pre-clinical stage through approval and life-cycle management, with potential focus on late stage/commercial programs

Proactively and effectively communicate risks and potential mitigations to teams and key stakeholders in a timely manner

Assess and communicate regulatory requirements to ensure all CMC activities are in compliance with applicable regulations and guidelines

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 initial INDs/CTAs, marketing applications, supplements and variations

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 initial INDs/CTAs, marketing registration applications, supplements and variations

Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of regulatory applications

Provide regulatory support for relevant quality systems such as change control, deviation t, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation

Develop, review, and maintain Regulatory CMC departmental policies and SOPs

Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines, and other international regulatory regulations and guidelines, as needed to support global clinical and commercial programs

Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices

Some travel may be required

Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans

Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any

Other duties as assigned

Qualification

Regulatory AffairsCMC StrategiesRegulatory SubmissionsManagement ExperienceFDA/EMA RegulationsMicrosoft ExcelVeeva RIMCommunication SkillsTeam CollaborationDetail Oriented

Required

A Bachelor's, Master's, or PhD in a scientific, medical, or regulatory discipline and 10+ years of management experience or combination of degrees and experience of progressively responsible Regulatory Affairs in a pharmaceutical, biotechnology, or related environment required

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, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members

Proficiency with Microsoft Excel, PowerPoint, Project, and Word programs

Preferred

Experience in rare disease indications and/or orphan drug development is desirable

Prior Regulatory Agency liaison experience is desirable

Experience with Veeva RIM is desirable

Benefits

Medical

Dental

Vision

Short-& long-term disability

Accidental death & dismemberment

Life insurance programs

Employee Assistance Program

Travel insurance

Retirement savings programs with company matching contributions

Vacation

Personal days

Sick days

End-of-year company shutdown

Training, Learning & Development program

Tuition Assistance program for advanced degrees

Company

Xenon Pharmaceuticals Inc.

Xenon Pharmaceuticals is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need.

Founded in 1996

Burnaby, British Columbia, CAN

201-500 employees