Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Biologics

Key Responsibilities

• Deep technical knowledge of biologics CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
• Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
• Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.
• Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
• Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
• Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

Basic Qualifications/Requirements

• B.S. degree in a science, engineering, or a related STEM field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of biologics. Those with greater than ten years of experience are encouraged to apply.

Additional Skills/Preferences

• Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
• Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.
• Relevant experience in biologics drug substance and/or drug product development, commercialization, or manufacturing.
• Demonstrated deep knowledge of the biologics drug development process.
• Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
• Experience planning for and participating in Health Authority meetings.
• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.