Senior Director, Regulatory & Scientific Affairs

Join The CTI Team • Covington, KY

14h • Hybrid

About The Position

The Senior Director, Regulatory and Scientific Affairs, is responsible for developing and executing global regulatory strategies to support the advancement of clinical development programs from early development through registration and lifecycle management. This role will advise sponsors on regulatory pathways and ensure that regulatory strategies align with their clinical, scientific, and corporate goals. The Senior Director, RSA will provide expert guidance on regulatory requirements, risk mitigation, and health authority engagement, ensuring regulatory strategies are scientifically sound, operationally feasible, and aligned with global regulatory expectations. The individual serves as a strategic partner to sponsors and internal cross-functional teams. This role also contributes to business development activities, including proposals, capabilities meetings, and pipeline development, and plays a critical role in establishing CTI as a strategic regulatory partner to sponsors.

Requirements

• Advanced degree in life sciences or clinical discipline: MD, PharmD, PhD, or master’s Level advanced scientific degree
• Minimum 10 years of regulatory affairs and/or clinical development experience in CRO, biotech, or pharmaceutical environments
• Demonstrated experience serving as a regulatory strategy lead across multiple programs
• Experience advising sponsors and supporting complex regulatory strategy
• In-depth experience in communication with clients and internal teams
• Experience providing expert knowledge of the drug and/or device development process and associated regulatory requirements
• Experience providing advanced technical skills in Microsoft Office including Word, PowerPoint, Excel, and ability to quickly learn and adapt to new systems and technologies
• Experience in preparation of technically complex documents intended for submission to regulatory authorities (e.g., briefing documents, clinical study reports)
• Demonstrated history of direct interaction with regulatory agencies (e.g., FDA, EMA, Health Canada)
• Proven expertise as a Clinical or Regulatory lead managing drug and/or device development projects pre- and post-marketing
• Experience providing Expert knowledge of ICH Good Clinical Practice guidelines and applicable regulatory requirements
• Experience mentoring or developing regulatory professionals

Responsibilities

• Serve as a regulatory strategy lead and scientific advisor for sponsor programs across multiple therapeutic areas.
• Develop and advise on global regulatory strategies supporting clinical development programs from early phase through registration and post-approval.
• Provide strategic guidance on regulatory pathways, clinical development plans, and regulatory risk mitigation.
• Advise sponsors and internal teams on regulatory requirements, regulatory precedents, and optimal development approaches.
• Lead development of regulatory strategy for health authority interactions (FDA, EMA, MHRA, and other global agencies), including Pre-IND/Scientific Advice meetings; end of phase meetings; Type A, B, and C meetings; Pre-BLA/NDA/MAA meetings.
• Develop briefing packages, regulatory questions, and regulatory meeting strategy.
• Advise sponsors on regulatory positioning, regulatory risk, and agency expectations.
• Provide regulatory and scientific expertise to support successful regulatory outcomes.
• Provide regulatory and scientific expertise across CTI programs, including protocol design, endpoint selection, safety strategy, and development planning.
• Collaborate with Medical Affairs, MID, Clinical Operations, Pharmacovigilance, and Biostatistics to ensure regulatory and scientific alignment.
• Support regulatory and scientific strategy across complex and innovative programs, including rare disease, transplantation, advanced therapies, and biologics.
• Serve as a regulatory and scientific subject matter expert in sponsor interactions, proposals, and capabilities meetings.
• Support growth of CTI’s regulatory consulting and scientific affairs capabilities.
• Provide regulatory leadership and guidance to internal teams across CTI.
• Provide strategic input into protocol development and study design.
• Monitor evolving regulatory guidance, regulatory precedents, and scientific developments.
• Apply regulatory intelligence to support sponsor strategy and internal decision-making.
• Provide regulatory and scientific insights to CTI leadership and sponsors.
• Support internal KPI development related to strategic regulatory performance.
• Contribute to thought leadership activities and external scientific visibility.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree