Director / Senior Director, Regulatory CMC (Biologics)

Oruka Therapeutics; Waltham (MA); On-site; 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

Director / Senior Director, Regulatory CMC (Biologics)

Waltham, Massachusetts, United States

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

Role Overview

We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross‑functional teams on phase‑appropriate global regulatory expectations. You bring deep expertise in biologics development and manufacturing, with strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program‑level objectives.

Key Responsibilities

• Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)
• Lead development of high‑quality CMC dossiers, timelines, and submission strategies for global filings
• Serve as the CMC regulatory SME on program teams, influencing cross‑functional decisions and overall development strategy
• Collaborate with CMC, Supply Chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures
• Lead cross‑functional coordination to plan and deliver timely, high‑quality responses to CMC regulatory information requests
• Ensure all submissions meet phase‑appropriate expectations and align with FDA, EMA, ICH, and WHO guidelines
• Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track
• Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents
• Guide late‑stage development planning, including process characterization, PPQ, and readiness for commercial filings
• Bring a clear, proactive, solution‑oriented mindset with the attitude to manage competing priorities
• Thrive in a fast‑paced biotech environment where agility and accountability matter
• Contribute to a culture of collaboration, transparency, and continuous improvement

Qualifications

• MS or PhD in life sciences with 10+ years of experience in a biologics‑focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
• Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
• Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA, etc.)
• Broad experience across development stages from early development through late stage and commercialization; hands‑on experience with BLA CMC submission is ideal
• Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf‑life strategy
• Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution
• Experience building alignment across teams (CMC, QA, Supply chain, RA and PM) in a fast‑paced biotech environment
• Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

Compensation & Benefits

Compensation will include a competitive base salary, equity, and performance‑related bonus opportunity.

Salary range: $213,000 – $286,000 USD for Director or Senior Director, depending on experience and qualification. Salaries may vary by state.

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients
• Competitive salary and benefits package
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work
• Opportunities for professional growth and development

EEO Statement

Oruka Therapeutics’s Equal Employment Opportunity policy ensures that we do not discriminate on the basis of any protected group status under any applicable law.