Director, Regulatory Affairs, CMC

Role Overview

• 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.

Requirements

• 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
• Experience in rare disease indications and/or orphan drug development is desirable.
• 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.
• Prior Regulatory Agency liaison experience is desirable.
• 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.
• Experience with Veeva RIM is desirable.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 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
• Company shutdown at end of year
• Training, Learning & Development program including Tuition Assistance program for advanced degrees