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Associate Director, Regulatory CMC (Biologics)

Oruka Therapeutics · Waltham, MA · 4 days ago
Hybrid$181k/yrFull-time

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.

Job Title

Associate Director, Regulatory CMC (Biologics)

Location

Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.

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 e.g., 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
  • Lead regulatory CMC risk assessment and develop potential mitigation strategies in a timely manner
  • 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 with emphasis on 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 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
  • A creative and strategic attitude with the ability to work in a fast-paced environment
  • A strong sense of urgency and ability to deliver in a highly fast paced environment

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 $181,000 to $208,000. 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.

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

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