---
title: 'Director / Senior Director, Regulatory CMC (Biologics) at Oruka Therapeutics'
canonical: 'https://feeny.ai/job/director-senior-director-regulatory-cmc-biologics-oruka-therapeutics-waltham-t568r4c74pmj'
type: 'job'
last_seen: '2026-09-16'
---

# Director / Senior Director, Regulatory CMC (Biologics) at Oruka Therapeutics

- **Company:** Oruka Therapeutics
- **Location:** Waltham Massachusetts, United States
- **Compensation:** $213k–$286k
- **Posted:** 2026-04-10
- **Last confirmed live:** 2026-09-16
- **Apply:** https://job-boards.greenhouse.io/oruka/jobs/5184371008

## Job description

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](http://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.

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, 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

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, 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

Compensation:

- An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
- The anticipated salary range for candidates, who will work in Waltham, MA, is $213,000-240,000 for Director and $255,00-286,000 for Senior Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day. Salary Range for the Role $213,000—$286,000 USD

What We Offer:

- 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.

## About Oruka Therapeutics

## Company Overview
- **One-liner**: Oruka Therapeutics is a clinical-stage biotechnology company developing potentially best-in-class monoclonal antibodies with extended half-lives to transform the treatment of psoriasis and other chronic inflammatory skin diseases by enabling high rates of complete disease clearance with as few as one or two doses per year.
- **Entity Type**: Public (Nasdaq: ORKA)
- **Headquarters**: Waltham, Massachusetts, United States (with a second office in Menlo Park, California)
- **Founded**: Not publicly available
- **Founders**: Not publicly available (the company was formed as a spinout of Paragon Therapeutics, which discovered its antibody pipeline)

## Core Business
- **Primary industry**: Biotechnology – dermatology and inflammatory disease therapeutics
- **Target customers**: Patients with plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and other inflammatory conditions; physicians and healthcare providers; payers and health systems
- **Mission**: *“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.”* [orukatx.com](https://orukatx.com/)

## Products & Services
- **ORKA-001**: An investigational monoclonal antibody targeting IL-23p19, engineered for extended circulation time. Designed as a potentially best-in-class therapy for moderate-to-severe plaque psoriasis, with the potential for dosing once or twice per year. Currently in Phase 2b clinical trial (EVERLAST-B). [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-002**: An investigational monoclonal antibody targeting IL-17A/F, also engineered for half-life extension. Aimed at psoriasis, psoriatic arthritis, and hidradenitis suppurativa, with potential dosing two to three times per year. Currently in Phase 1/2. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-003**: A preclinical sequential combination regimen of ORKA-002 and ORKA-001, designed to deliver rapid responses with an ideal maintenance profile. [orukatx.com](https://orukatx.com/our-pipeline/)
- **ORKA-021**: Preclinical stage candidate (details not fully disclosed). [orukatx.com](https://orukatx.com/our-pipeline/)

## Market Standing
- **Valuation/Market Cap**: Not publicly available at this time (company went public via IPO; market cap fluctuates daily). Latest financial data should be obtained from SEC filings.
- **Key Metric**: As a clinical-stage public company, Oruka has no approved products yet. Funding and operational runway are funded by its IPO proceeds; exact amounts not provided in search results.
- **Notable Investors/Partners**: Discovery and engineering partner: Paragon Therapeutics (also parent of Apogee Therapeutics and Spyre Therapeutics). Investor base includes public market shareholders post-IPO.
- **Growth Signals**: 
  - Two co-lead programs advancing through clinical trials (Phase 1 data expected; Phase 2 ongoing).
  - Team expanding rapidly, with multiple job openings across scientific, clinical, and corporate functions.
  - Dual-location offices (Boston area and Bay Area) to attract top biotech talent.

## Competitive Advantages
- **Advanced antibody engineering**: Incorporates half-life extension technology (e.g., YTE mutations) to dramatically prolong circulation time, aiming for the longest dosing intervals in the class (1–2 doses per year vs. standard 4–12 times per year).
- **Proven mechanisms**: Targets IL-23p19 and IL-17A/F—validated, blockbuster pathways in psoriasis—but with enhanced pharmacokinetics to maximize efficacy and patient convenience.
- **Discovery engine**: Pipeline originated from Paragon Therapeutics, a proven antibody engineering shop that also spawned Apogee and Spyre, indicating a repeatable model for creating best-in-class molecules.
- **Focus on complete clearance**: Emphasizes “complete disease clearance” (e.g., PASI 100) as a goal, not just improvement—a higher bar than many current treatments.

## Strategic Focus
- **Near-term**: Generate Phase 1 safety and pharmacokinetics data for ORKA-001 and ORKA-002; advance EVERLAST-B (Phase 2b for ORKA-001) and ORCA-SURGE (Phase 2 for ORKA-002); initiate trials in additional indications (psoriatic arthritis, hidradenitis suppurativa).
- **Long-term**: Build a fully integrated biopharmaceutical company capable of commercializing novel biologics, potentially expanding beyond dermatology into other inflammatory diseases.
- **Organizational growth**: Aggressively hiring across all functions (clinical development, medical affairs, regulatory, CMC, finance, BD, etc.) to scale from early-stage to late-stage organization.

## Why Work Here
- **Mission-driven**: A chance to directly impact millions of patients living with chronic skin diseases—offering the potential for life-changing freedom from disease.
- **Startup culture with public-company resources**: Small, nimble team (“wear multiple hats”) but with the backing of a Nasdaq listing, equity grants, and competitive compensation.
- **Flexible work environment**: Remote-first policy with hybrid options (3 days/week) if located near Waltham, MA or Menlo Park, CA offices. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Compensation & benefits**: Competitive base salary (e.g., Senior Scientific Communications Manager salary range $161k–$187k), equity, performance bonus, and professional development opportunities. [greenhouse.io](https://job-boards.greenhouse.io/oruka/jobs/5202407008)
- **Team culture**: Described as “vibrant startup culture,” “supportive and inclusive,” with emphasis on bringing “authentic selves to work.” Opportunities for growth in a fast-moving, high-autonomy environment.
- **Top-tier location**: Offices in both the Boston/Cambridge biotech hub and the Bay Area, giving employees access to two of the strongest life science ecosystems.

## Sources
1. [orukatx.com – Home](https://orukatx.com/)
2. [orukatx.com – Who We Are](https://orukatx.com/who-we-are/)
3. [orukatx.com – Pipeline](https://orukatx.com/our-pipeline/)
4. [orukatx.com – Join Us](https://orukatx.com/join-us/)
5. [greenhouse.io – Senior Scientific Communications Manager job posting](https://job-boards.greenhouse.io/oruka/jobs/5202407008)

## Other roles at Oruka Therapeutics

- [Trial Master File (TMF) Associate](https://feeny.ai/job/trial-master-file-tmf-associate-oruka-therapeutics-menlo-park-california-m7m73f19sw65) — Menlo Park California, United States / Waltham Massachusetts, United States
- [Sr. Associate/Manager Project Management & Operations](https://feeny.ai/job/sr-associate-manager-project-management-operations-oruka-therapeutics-waltham-vkjrt9srrzv7) — Waltham Massachusetts, United States
- [Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization](https://feeny.ai/job/senior-manager-associate-director-clinical-monitoring-strategy-optimization-fz8n0jqr0913) — Menlo Park California, United States / Waltham Massachusetts, United States
- [Associate Director, Regulatory CMC (Biologics)](https://feeny.ai/job/associate-director-regulatory-cmc-biologics-oruka-therapeutics-waltham-8tegt1p70qg9) — Waltham Massachusetts, United States
- [Associate/Sr. Associate - CMC Project Management & Operations](https://feeny.ai/job/associate-sr-associate-cmc-project-management-operations-oruka-therapeutics-nxqjhp0d3ycd) — Waltham Massachusetts, United States
- [Associate Director/Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-oruka-therapeutics-remote-mszse4yzs07a)
- [Biosample Operations Associate](https://feeny.ai/job/biosample-operations-associate-oruka-therapeutics-menlo-park-california-4cggc3qztsw9) — Menlo Park California, United States / Waltham Massachusetts, United States
- [Administrative Assistant](https://feeny.ai/job/administrative-assistant-oruka-therapeutics-waltham-w7s67gb88efv) — Waltham, MA
- [Sr. Manager/Associate Director, Regulatory Affairs](https://feeny.ai/job/sr-manager-associate-director-regulatory-affairs-oruka-therapeutics-menlo-park-810qkwnjxqp4) — Menlo Park, CA / Waltham, MA
- [Director, Clinical Operations](https://feeny.ai/job/director-clinical-operations-oruka-therapeutics-waltham-massachusetts-dmf2nbp3y8nt) — Waltham Massachusetts, United States