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$181k–$208k/yr
Full-time
postgraduate degree
Competitive Base Salary, Equity, Performance-related Bonus, Professional Growth and Development Opportunities
Posted 23d ago
~40 hrs/week
Responsibilities
Develop and execute regulatory CMC strategies and author high-quality dossiers for global submissions including IND, IMPD, and BLA. Act as the primary SME for CMC in cross-functional meetings and manage interactions with global regulatory agencies.
Requirements
Requires a Master's or PhD in life sciences with 6-8 years of CMC experience and at least 3 years specifically in biologics regulatory CMC. Must have a proven track record with FDA/EMA submissions and expertise in combination drug/device regulations.
Full 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
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.
Location: Hybrid – Waltham, MA. Candidates will be required to be in-office3 days/week.
We are seeking an experienced and motivated candidate to develop regulatory CMC strategy in support of early-to-late-stage clinical programs. In this role, you will be responsible for authoring high quality regulatory CMC submission while guiding CMC teams on relevant phase appropriate global regulatory guidelines. You are an ideal candidate for this role if you have experience in biologics development and manufacturing with significant exposure to regulatory CMC submissions. In this role, you will have the opportunity to 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.
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
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
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)
Must have experience in authoring and reviewing combination drug/device related Module 3 submissions
Exposure to the phase appropriate development of design control and validation protocols, URRAs, DHFs, and human factor studies
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
Must have a creative and strategic attitude with the ability to work in a fast-paced environment
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.
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
$182,000—$208,000 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.
Related keywords
CMCBiologicsRegulatory AffairsMonoclonal AntibodiesFDAEMAICHWHOCombination ProductsISO Standards21 CFR Part 4MDR/IVDRcGMPINDIMPDBLA
How much do Science & Research jobs in Massachusetts pay?
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