Director, Regulatory CMC Strategy

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

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

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

• Lead the preparation, review, and approval of CMC materials for INDs, CTAs, marketing applications, supplements/variations, briefing documents, and information requests from health authorities.

• Monitor and analyze 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 readiness for manufacturing.

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

• Manage project timelines, budgets, forecasts, and strategies for risk mitigation.

• Foster relationships with internal stakeholders and external partners to further programs and organizational objectives.

⛳️ 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 8 years of experience in the pharmaceutical industry, with at least 5 years in Regulatory CMC roles focused on small molecule development programs.

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

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

• Strong understanding of the development of small molecule drug substances and products, analytical development, manufacturing processes, control strategies, and principles of pharmaceutical development.

• Significant experience in managing CDMOs and external development and manufacturing partners.

• A thorough understanding of cGMP regulations, 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.

• Strong leadership, project management, communication, and collaboration skills across functions.

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

🏝️ Benefits

• Company bonus based partially on individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Paid vacation benefits.

• Comprehensive medical benefits.

• Dental benefits coverage.

• Vision benefits included.

• Prescription drug coverage.

• Flexible spending accounts for healthcare.

• Flexible spending accounts for dependent daycare.

• Life insurance and death benefits provided.

• Time off and leave of absence benefits available.

• Employee assistance program offered.

• Fitness benefits for employees.

• Employee clubs and activities to engage with.