Senior Director, Regulatory CMC

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

📋 Description

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

• Offer strategic and technical guidance across drug substance, drug product, analytical development, manufacturing, and control functions.

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

• Provide regulatory insight on development plans, regulatory risk evaluations, lifecycle management, and expectations from health authorities.

• Lead the preparation, review, and approval of CMC content for global regulatory submissions and responses, including INDs, CTAs, marketing applications, supplements/variations, briefing packages, and health authority information requests.

• Monitor and analyze shifting global regulatory requirements, guidance, and precedents.

• Oversee external development and manufacturing partners, including CDMO selection, oversight, performance management, technology transfer, 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 mitigation strategies.

• Foster strong relationships with both internal stakeholders and external partners.

⛳️ Requirements

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

• A minimum of 12 years of experience in the pharmaceutical industry, including at least 5 years in Regulatory CMC roles focusing on small molecule development programs.

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

• Proficient in authoring, reviewing, and managing CMC regulatory filings, such as INDs, IMPDs, NDAs, and interactions with global health authorities.

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

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

• Comprehensive knowledge of cGMP requirements, ICH guidelines, FDA regulations, and global Regulatory CMC expectations.

• Experience in supporting programs 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 abilities.

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

🏝️ Benefits

• Company bonus based, in part, on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

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

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

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