Senior Director, Regulatory CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement comprehensive Regulatory CMC strategies for small molecule programs, spanning from preclinical development to late-stage clinical development and regulatory submissions.

• Deliver strategic and technical leadership across drug substance, drug product, analytical development, manufacturing, and control operations.

• Act as the Regulatory CMC subject matter expert within cross-functional program teams.

• Align CMC development strategies with clinical, regulatory, quality, and business goals.

• Provide regulatory insights on development strategies, risk assessments, lifecycle management, and expectations from health authorities.

• Lead the preparation, review, and approval of CMC documentation for global regulatory submissions and responses, which includes INDs, CTAs, marketing applications, supplements/variations, briefing packages, and inquiries from health authorities.

• Monitor and analyze changes in global regulatory requirements, guidance, and precedents.

• Oversee external development and manufacturing partners, focusing on CDMO selection, supervision, performance management, technology transfers, scale-up, validation, and manufacturing readiness.

• Ensure adherence to FDA, EMA, ICH, and cGMP standards while facilitating inspection readiness and supply continuity.

• Create and manage project plans, timelines, budgets, forecasts, and risk management strategies.

• Cultivate relationships with internal stakeholders and external partners to promote program advancement and achieve organizational objectives.

• Report directly to the Executive Director of Regulatory CMC.

⛳️ Requirements

• A Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field is required; PharmD or PhD is preferred.

• At least 12 years of experience in the pharmaceutical industry, with a minimum of 5 years in Regulatory CMC roles supporting small molecule development programs.

• Recent experience in leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions.

• Proven experience in authoring, reviewing, and managing CMC regulatory submissions, including INDs, IMPDs, NDAs, and interactions with global health authorities.

• Robust knowledge of small molecule drug substance and product development, analytical development, manufacturing processes, control strategies, and pharmaceutical development principles.

• Extensive experience in managing CDMOs and external development and manufacturing organizations.

• Comprehensive understanding of cGMP requirements, ICH guidelines, FDA regulations, and global Regulatory CMC standards.

• Experience supporting projects from early development through IND submission and lifecycle management.

• Familiarity with technology transfer, process development, scale-up, validation, and clinical supply manufacturing activities.

• Exceptional leadership, project management, communication, and cross-functional collaboration skills.

• Experience in orexin, CNS, or other specialized therapeutic areas is preferred.

• Must reside in the United States.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension benefits.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.

• Remote work options available.

• Occasional travel required.