Director / Senior Director, Regulatory CMC (Biologics)

Benefits

Parental leave

Not verified

Non-birth-parent leave

Not verified

Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

Not verified

Relocation assistance

Not verified

Childcare support

Not verified

Learning budget

Not verified

Verification

Not verified

Salary

$213K-$286K From the posting source checked Jun 20, 2026

401(k) match

Not verified

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

303% above the BLS role benchmark for operations aggregate.

Posted salary is far from this role benchmark; treat it as low confidence.

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function

Operations From the posting source checked Jun 20, 2026

Seniority

Director Plus From the posting source checked Jun 20, 2026

Schedule

Shift type

Not verified

Weekend work

Not verified

Company

Company stage

Public-company From the posting source checked Jun 20, 2026

Equity

Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter

Not verified

Assessment

Not verified

Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Director / Senior Director, Regulatory CMC (Biologics) Waltham, Massachusetts, United States 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 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

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