Biologics Regulatory CMC Director — Hybrid & Equity

Oruka Therapeutics; Waltham (MA); Hybrid; USD 213,000 - 286,000; Full time

Benefits offered by this job

Equity options

Performance-related bonus

Professional growth opportunities

Supportive team environment

Job summary

A biotechnology company based in Waltham, Massachusetts is looking for a Director / Senior Director, Regulatory CMC. This role involves owning the global regulatory CMC strategy, leading submissions aligned with FDA and EMA guidelines, and fostering collaboration across teams. Candidates should have a minimum of 10 years in biologics CMC roles and a strong track record in drug substance development and regulatory submissions. The position offers a competitive salary between $213,000 and $286,000 plus a benefits package and a hybrid work model.

Qualifications

• 10+ years of experience in a biologics-focused CMC role.
• Minimum of 5+ years of direct regulatory CMC experience.
• Strong command of cGMPs and global regulatory expectations.

Responsibilities

• Drive global regulatory CMC strategy for drug substance and product.
• Lead high-quality CMC dossier development and submission strategies.
• Anticipate regulatory risks and develop mitigation strategies.

Skills

Regulatory CMC

Biologics development

Project management

FDA regulations

Communication skills

Education

MS or PhD in life sciences

Job description

A biotechnology company based in Waltham, Massachusetts is looking for a Director / Senior Director, Regulatory CMC. This role involves owning the global regulatory CMC strategy, leading submissions aligned with FDA and EMA guidelines, and fostering collaboration across teams. Candidates should have a minimum of 10 years in biologics CMC roles and a strong track record in drug substance development and regulatory submissions. The position offers a competitive salary between $213,000 and $286,000 plus a benefits package and a hybrid work model.