Oruka Therapeutics

Oruka Therapeutics

Director / Senior Director, Regulatory CMC (Biologics)

Waltham, Massachusetts, United States · Director

Sponsorship not specified$213k-$240kDetected 103 days ago
Supply ChainFDA RegulatoryCommunicationCollaboration

About the role

  • We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs.
  • 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.

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
  • 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
  • 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
  • Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities

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
  • 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
  • Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines
  • 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
  • Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment

Nice to have

  • 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

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.

Benefits

  • Competitive salary and benefits package.

Company info

  • 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)
  • 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.
  • A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
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