Associate Director, Regulatory CMC (Biologics)

Oruka Therapeutics; Waltham (MA); Hybrid; USD 181,000 - 208,000; Full time

Benefits offered by this job

Startup culture

Competitive benefits package

Inclusive team environment

Growth opportunities

Job summary

Oruka Therapeutics in Waltham, MA is seeking an Associate Director, Regulatory CMC (Biologics) to lead regulatory CMC strategy for late-stage programs, author submissions, and guide cross-functional teams.

The role requires an advanced life sciences degree and 6–8 years in a CMC-focused role with biologics, plus experience with FDA/EMA and device regulations; offering competitive salary and equity in a fast-paced startup culture.

Qualifications

• Master’s or PhD in a life sciences discipline with 6–8 years in a CMC-focused role in biologics
• Regulatory CMC expertise across early‑to‑late stage development and approvals
• Experience interacting with FDA, EMA and global regulatory agencies regarding CMC submissions

Responsibilities

• Develop regulatory CMC dossiers, timelines and deliverables for global submissions (IND, IMPD, BLA)
• Serve as regulatory CMC SME in cross‑functional meetings with internal and external partners
• Lead strategy for combination drug/device regulations and ISO/FDA/EMA guidelines
• Coordinate with CMC, QA, RA, Supply Chain and CDMOs on amendments and changes
• Mentor teams and drive timely regulatory risk assessment and mitigation

Skills

Writing

Organization

Communication

People management

Strategic thinking

Urgency

Education

Master’s or PhD in life sciences

Job description

Associate Director, Regulatory CMC (Biologics)

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

About Us: 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.

This role is a highly visible position within the company, pivotal to supporting multiple campaigns in a fast-growing biologics pipeline. You will develop regulatory CMC strategy for early‑to‑late‑stage clinical programs, author high‑quality regulatory CMC submissions, and guide CMC teams on phase‑appropriate global regulatory guidelines. Collaboration, communication, and problem solving are essential to meet program and corporate objectives.

Key Responsibilities:

• Develop regulatory CMC dossiers, timelines and deliverables in support of global regulatory submissions (IND, IMPD, BLA).
• Provide strategic guidance while acting as the key regulatory CMC SME in cross‑functional meetings with internal and external partners.
• Partner with stakeholders to respond to requests from regulatory agencies involving drug substance and aseptic drug product manufacturing, including drug/device combination products.
• Liaise with key internal (CMC, QA, RA, and Supply Chain) and external stakeholders (CDMOs) to develop dossiers including amendments related to manufacturing, specifications or stability protocol changes.
• Lead regulatory strategy in support of combination product development (design control and validation, DHF, human factor studies, and bridging studies).
• Manage regulatory CMC submissions and ensure content is in line with combination drug device guidelines including ISO standards, FDA (21 CFR Part 4), and EMA (MDR/IVDR).
• Ensure regulatory CMC submissions meet phase‑appropriate standards and are compliant with FDA, EMA, ICH and WHO guidelines.
• Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life and change control procedures.
• Serve as the Regulatory CMC SME in internal and external forums and partner with regulatory program leads in support of global submissions.
• Track amendment deliverables and adapt to changing priorities keeping corporate CMC objectives at the forefront.
• Lead regulatory CMC risk assessment and develop potential mitigation strategies in a timely manner.
• Facilitate critical cross‑functional decisions within the CMC team while keeping program‑level stakeholders informed at regular intervals.
• Develop road map for late‑stage process development, process characterization, and PPQ campaigns.
• Foster a culture of collaboration, communication, critical thinking, innovation, and continuous improvement.

Qualifications:

• Master’s or a PhD in a life sciences discipline with 6–8 years of experience in a CMC‑focused role and a minimum of 3+ years of regulatory CMC experience in biologics.
• Significant exposure to cGMPs, biologics development, manufacturing regulations and guidelines involving biologics, especially monoclonal antibodies.
• Regulatory CMC expertise from early‑stage preclinical development through various stages of clinical development and marketing approvals.
• Successful track record of managing interactions with the FDA, EMA and other global regulatory agencies related to CMC submissions.
• Exposure to global combination drug/device regulations including relevant ISO standards, FDA (21 CFR Part 4), and EMA (MDR/IVDR).
• Experience authoring and reviewing combination drug/device related Module 3 submissions.
• Exposure to the phase‑appropriate development of design control and validation protocols, URRAs, DHFs, and human factor studies.
• Experience with liquid formulation studies, process development, container closure compatibility studies, device functionality studies and QTPP development.
• In‑depth knowledge of aseptic regulations required to manage multi‑country regulatory filings.
• Strong scientific skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
• Excellent writing, organization, communication and people‑management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Creative and strategic attitude with the ability to work in a fast‑paced environment.
• Strong sense of urgency and ability to deliver in a highly fast‑paced environment.

Compensation:

• Competitive base salary and equity, with a performance‑related bonus opportunity.
• Salary range: $181,000 to $208,000 (Waltham, MA); final salary will depend on experience, education, etc.

What We Offer:

• 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.
• Supportive and inclusive team environment encouraging authenticity.
• Opportunities for professional growth and development.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.