Associate Director, Regulatory CMC (Biologics)

Oruka Therapeutics•Waltham, MA

1d•Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming to provide patients with significant relief through infrequent dosing. The company is seeking an experienced candidate to develop regulatory CMC strategy for early-to-late-stage clinical programs. This role involves authoring high-quality regulatory CMC submissions and guiding CMC teams on global regulatory guidelines. The ideal candidate will have experience in biologics development and manufacturing, with substantial exposure to regulatory CMC submissions. This is a highly visible position within a growing organization, offering the opportunity to support a fast-growing biologics pipeline and foster collaboration to achieve key objectives.

Requirements

Master’s or a PhD in a life sciences discipline
6-8 years of experience in a CMC focused role
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

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