Associate Director, Regulatory CMC (Biologics

Associate Director, Regulatory CMC (Biologics)

Waltham, Massachusetts, United States

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.

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.

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

Develop regulatory CMC strategy in support of early-to-late-stage clinical programs. Author high quality regulatory CMC submissions while guiding CMC teams on relevant phase appropriate global regulatory guidelines. Experience in biologics development and manufacturing with significant exposure to regulatory CMC submissions is required. Foster strong collaboration, communication, and problem solving to meet key program and corporate objectives. This is a highly visible role and a pivotal addition to our growing organization where you will play an integral role in supporting multiple campaigns in support of a fast-growing biologics pipeline.

• 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
• Serves 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

• 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…