Senior Director, Regulatory & Scientific Affairs

Senior Director, Regulatory & Scientific Affairs

Job Category: Reg & Scientific Affairs

Requisition Number: SENIO

• Posted : March 9, 2026
• Full-Time
• Remote

Locations

Showing 1 location

United States - Remote
100 E Rivercenter Blvd.
Ste 1600
Covington, KY 41011, USA

We are seeking an accomplished Senior Director, Regulatory Strategy & Affairs (RSA) with deep expertise in CMC, non‑clinical development, cell and gene therapy (CGT) regulatory strategy, and medical device/combination product requirements. This role will serve as a senior subject‑matter expert responsible for shaping global regulatory strategies for advanced modalities and ensuring programs meet evolving regulatory expectations in CMC, non‑clinical, and device pathways.

What You’ll Do:

CMC & Cell and Gene Therapy (Ideally)

• Lead CMC regulatory strategy for biologics and cell and gene therapy products, including viral vector platforms, cell‑based products, and other novel modalities.
• Guide CMC comparability, potency strategy, analytical characterization, process development, and control‑strategy expectations specific to CGT.
• Develop global regulatory strategies addressing ATMP requirements, RMAT designations, and CGT‑specific CMC submissions.
• Advise cross‑functional teams on evolving CGT regulatory frameworks (e.g., FDA, EMA, MHRA) and associated expectations for manufacturing, testing, and lifecycle changes.

Non‑Clinical Strategy (Critical Area)

• Provide expert regulatory guidance on non‑clinical development, including:
• Toxicology and pharmacology program design
• Biodistribution, shedding, and persistence studies for CGTs
• Immunogenicity and tumorigenicity assessments
• Ensure non‑clinical strategies align with global agency requirements for first‑in‑human, early‑phase, and pivotal development.

Device / Combination Products

• Lead regulatory strategy for medical device and combination product components, including EU MDR, FDA device pathways, and device‑specific documentation.

Cross‑Functional Leadership & Global Agency Interface

• Represent programs in global health authority interactions for CMC, non‑clinical, and device topics.
• Lead preparation of IND/CTA submissions, IMPDs, BLA/NDA/MAA content, and briefing packages.
• Mentor team members and help build internal regulatory capability in advanced modalities and specialized CMC/non‑clinical domains.

Lead global CMC regulatory strategy for assigned programs, guiding early development through registration and lifecycle management. Experience in Cell and Gene Therapy would be:

• Provide expert regulatory input on non‑clinical study design, strategy, and data interpretation to ensure alignment with global health authority expectations.
• Serve as regulatory lead for medical device and combination product strategy, including MDR, FDA device pathways, and device‑related submission content.
• Develop, author, and review high‑quality global regulatory documents, including IND/CTA submissions, IMPD, BLA/NDA/MAA components, and agency briefing packages.
• Lead interactions with global health authorities (FDA, EMA, MHRA, etc.) for CMC, non‑clinical, and device topics, representing program strategies and negotiating key decisions.
• Drive regulatory risk identification, mitigation strategies, and scenario planning across development teams.
• Serve as a senior advisor to cross‑functional leadership teams, ensuring regulatory considerations are integrated into project plans and decisions.
• Support organizational capability building by mentoring team members and contributing to best‑practice development within Regulatory Affairs.

What You’ll Bring:

• Advanced degree (PhD, PharmD, MS) in life sciences, chemistry, bioengineering, or related field.
• 12+ years of experience in Regulatory Affairs, with:
• Extensive leadership in CMC regulatory strategy
• Direct experience in cell and gene therapy regulatory development
• Deep understanding of non‑clinical regulatory requirements
• Experience with medical device/combination product pathways
• Demonstrated success in leading complex health authority interactions.
• Proven track record developing regulatory strategies for high‑complexity programs.
• Strong communication, leadership, and decision‑making skills.

Preferred Qualifications

• Experience with ATMPs, CAR‑T, viral vectors, stem‑cell therapies, or other advanced modalities.
• Late‑stage regulatory submission experience for CGT or biologics.
• People‑leadership experience or demonstrated mentorship.
• Experience working in global, matrixed development organizations.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award‑Winning and Valued Team – We have an award‑winning unparalleled culture that can be felt by our employees across 60 countries. We support a work‑life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically‑ill patients, who depend on us to bring life‑changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page.

Please Note

• We will never communicate with you directly via Microsoft Teams Messaging or by text message
• We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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