Director, Regulatory CMC (Biotech)

Location: Remote within any US state

Salary: $215,000–$235,000 per year, plus performance-based bonus and equity.

Company

Biopharmaceutical company developing novel therapeutic candidates for unmet needs in oncology.

What you will do

• Lead global Regulatory CMC strategies for clinical-stage and commercial small-molecule products.
• Author, review, and coordinate CMC content for INDs, CTAs, IMPDs, NDAs/MAAs, supplements, variations, annual reports, and regulatory responses.
• Assess manufacturing, analytical method, specification, stability, packaging, supplier, and manufacturing-site changes and define regulatory filing strategies.
• Conduct CMC gap assessments and develop remediation plans for technical, manufacturing, validation, stability, and quality documentation.
• Coordinate CMC deliverables across technical operations, quality, clinical, supply chain, commercial teams, CMOs, CDMOs, laboratories, and consultants.
• Lead health authority interactions, inspections, audits, due diligence activities, and regulatory negotiations.

Requirements

• Advanced degree in chemistry, pharmaceutical sciences, chemical engineering, or a related discipline.
• Generally 10+ years of pharmaceutical industry experience, including substantial Regulatory CMC experience and increasing responsibility for global regulatory strategy.
• Experience with small-molecule drug development and commercialization, clinical trial applications, marketing applications, post-approval changes, site transfers, supplier changes, stability strategies, and product lifecycle management.
• Expert knowledge of ICH guidelines, cGMP expectations, compendial standards, and FDA, EMA, NMPA, MFDS, and other global health authority requirements.
• Advanced proficiency in authoring and reviewing Module 3/CMC sections, briefing documents, information-request responses, annual reports, supplements, and variations.
• Strong scientific writing, communication, leadership, organization, and cross-functional collaboration skills.

Culture & Benefits

• Fully remote work within the United States.
• Unlimited vacation and 10 sick days annually.
• Medical, dental, and vision coverage.
• 401(k) with company matching.
• Performance-based bonus and long-term incentive equity plans.