Associate Director, Global Regulatory CMC

About the Role The Associate Director, Global Regulatory, CMC will coordinate regulatory CMC activities for one or more products, through all stages of a product's lifecycle. They will develop global regulatory CMC strategies, collaborate with key stakeholders to execute the strategies, and provide guidance to product teams. The role also includes preparation of CMC and quality-related agency correspondence and regulatory submissions. What You'll Do

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions.
• Perform assessment of manufacturing change controls.
• Support development of regulatory processes and procedures to support CMC components of regulatory submissions.
• Support the creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Provide interpretation of regulatory guidance documents, regulations and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs. What We're Looking For
• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 5+ years of experience in Biologics focused Regulatory CMC.
• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions.
• Knowledge of regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones.
• Ability to work independently.
• Exceptional written and oral communication.