Job Title: Associate Director, Regulatory CMC (Biologics)        

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 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.