Senior Director, Regulatory & Scientific Affairs

Senior Director, Regulatory & Scientific Affairs Job Summary:

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. What You'll Do

• 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 s.

..

Rate:

Not Specified Location:

Covington, US-KY Type:

Permanent Industry:

Finance Recruiter:

CTI Clinical Trial Services, Inc.

Contact:

Not Specified Email:

to view click here

Reference:

SENIO001708

Posted:

2026-03-11 07:50:24

• View all Jobs from CTI Clinical Trial Services, Inc. Apply Now Share Job More Jobs from CTI Clinical Trial Services, Inc. Production Manager Wash Aisle Operator Feeder-Folder Load Builder Shuttle Driver
• CDL Required Maintenance Technician Maintenance Worker Assistant Production Manager Feeder-Folder CDL B Driver Regional Sales Manager Chief Engineer Feeder-Folder Direct Support Professional (DSP)

Floater Lagermitarbeiter:

Codierer (m/w/d) in der Frühschicht Postbote

• Aushilfe (m/w/d) Postbote
• Aushilfe (m/w/d) Associate Recruiter Registered Nurse (Pulmonary/Renal) Assistant Director at Sheboygan KinderCare