Director / Senior Director, Regulatory CMC (Biologics)
Oruka Therapeutics, Waltham, MA, United States
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.
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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.
#J-18808-Ljbffr