Director / Senior Director, Regulatory CMC (Biologics)

Oruka Therapeutics • Waltham, MA

19h • $213,000 - $286,000 • Hybrid

About The Position

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Director / Senior Director, Regulatory CMC (Biologics)
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 are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including 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 that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.

Requirements

• 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.
• 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
• 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, QA, RA and PM) in a fast-paced biotech environment
• Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

Nice To Haves

• Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
• Hands-on experience with BLA CMC submission is ideal

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, HC, 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1-10 employees