Associate Director, Global Regulatory Sciences-CMC

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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Position Summary / Objective

The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director, Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate Director, Biologics will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.

Position Responsibilities

• Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research
• Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
• Independently manage and prioritize multiple complex projects
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
• Identify, communicate and propose resolutions to routine/complex issues
• Interpret global regulations and guidance. Identify regulatory opportunity and risks.
• Anticipate and communicate possible regulatory paradigm shifts
• Participate in product fact finding meetings
• Review and provide regulatory assessments on change controls
• Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents
• Mange relationships with diverse teams
• Utilize electronic systems for dossier creation and tracking.

Degree Requirements

Minimum BA/BS Degree

Experience Requirements

• 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy. 

• Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for small molecule products.

• Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods.

• Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead m