Director, Regulatory CMC Strategy

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

📋 Description

• Create and implement integrated Regulatory CMC strategies for small molecule programs throughout preclinical development to late-stage clinical development and regulatory submissions.

• Offer strategic and technical support 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 strategic regulatory advice on development strategies, regulatory risk evaluation, lifecycle management, and health authority expectations.

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

• Track and interpret changing global regulatory requirements, guidance, and precedents.

• Collaborate with external development and manufacturing partners, including oversight of CDMOs, performance management, technology transfer, scale-up, validation, and manufacturing readiness.

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

• Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies.

• Cultivate relationships with internal stakeholders and external partners to advance programs and meet organizational objectives.

⛳️ Requirements

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

• Over 8 years of experience in the pharmaceutical industry, with a minimum of 5 years in Regulatory CMC roles supporting small molecule development programs.

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

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

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

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

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

• Proven experience supporting programs from early development through IND submission and lifecycle management.

• Experience in supporting technology transfer, process development, scale-up, validation, and clinical supply manufacturing activities.

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

• Preferred experience in orexin, CNS, or other specialized therapeutic areas.

🏝️ Benefits

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

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Various time off and leave of absence benefits.

• Well-being benefits, which include an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups (ERGs) providing support networks.