Associate Director, Regulatory CMC

About Us

About the Role

The Associate Director, Regulatory CMC, will execute global regulatory CMC strategies in collaboration with key stakeholders.

Reporting to the Vice President, Regulatory CMC, you will provide expert guidance to manufacturing and quality teams, lead global regulatory submissions, act as primary liaison with Health Authorities for CMC aspects of programs, and interpret applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance, and contribute to department initiatives. You must have experience with biologics, specifically monoclonal antibodies, bispecifics, and / or fusion proteins or vaccines in order to be successful in this role.

This is a unique opportunity to join a growing organization with an expanding pipeline and play an integral role in the creation and implementation of regulatory strategies from early development through marketing approval. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provide leadership and strategic direction for regulatory CMC deliverables, including drug/device combination products.
• Identify, communicate, and propose resolutions to routine and complex strategic issues.
• Lead planning and provide hands on support for development, and on-time delivery of clear and effective global CMC regulatory submission documents.
• Act as primary contact with Health Authorities for CMC-related matters; lead preparation for and conduct of agency meetings.
• Maintain expert knowledge in US and international biopharmaceutical and combination product regulations and provide proactive regulatory intelligence.
• Review and provide regulatory assessments on change controls.
• Identify regulatory opportunities and risks and communicate them to project teams and senior management in a clear and concise manner.
• Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Identify, engage and collaborate with external regulatory experts and consultants.
• Support departmental initiatives, including process and infrastructure development, budgeting, and authoring of departmental documents, such as SOPs and Regulatory Development Plans.

Experience

• Bachelor's degree and a minimum of 8 years of experience in Regulatory CMC for biotherapeutics, biologics experience required; drug/device combination product experience a plus.
• Demonstrated track record of successful interactions with FDA and other Health Authorities related to CMC submissions.
• Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development.
• Preparation of Quality sections of regulatory dossiers, including IND/CTA/IMPDs, briefing documents, and BLA/MAAs.
• Preparation for and conduct of Regulatory CMC meetings with global Health Authorities for complex issues.
• Strong interpersonal skills and the ability to collaborate effectively with technical area experts.
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
• Excellent communication, writing, and presentation skills, with the ability to effectively convey critical information to project teams, senior management, and external stakeholders.
• Strong project management skills.
• Ability to work effectively in a fast-paced, collaborative, and dynamic environment.