Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls

This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post approval submissions.

What You Will Do

Deep technical knowledge of small molecule 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.

Why It Might Be a Fit

The ideal candidate will have a strong working knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.

Requirements

• B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred)
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules
• 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
• Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing
• Demonstrated deep knowledge of the synthetic molecule 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

Benefits

• Company bonus
• Comprehensive benefit program
• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)