Director / Senior Director, Regulatory CMC (Biologics)

Job Title: Director / Senior Director, Regulatory CMC (Biologics)       

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

Role Overview:

We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations. You are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.

Key Responsibilities: 

• Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)
• Lead development of high-quality CMC dossiers, timelines, and submission strategies for global filings
• Serve as the CMC regulatory SME on program teams, influencing cross-functional decisions and overall development strategy
• Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures
• Lead cross-functional coordination to plan and deliver timely, high-quality responses to CMC regulatory information requests
• Ensure all submissions meet phase-appropriate expectations and align with FDA, HC, EMA, ICH, and WHO guidelines
• Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track
• Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents
• Guide late-stage development planning, including process characterization, PPQ, and readiness for commercial filings
• Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities
• Thrive in a fast-paced biotech environment where agility and accountability matter
• Contribute to a culture of collaboration, transparency, and continuous improvement

Qualifications:

• MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
• Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
• Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)
• Broad experience across development stages from early development through late stage and commercialization; Hands-on experience with BLA CMC submission is ideal
• Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf-life strategy
• Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution
• Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment
• Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

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 $213,000-240,000 for Director and $255,00-286,000 for Senior Director. 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.