CTI Clinical Trial and Consulting Services

Senior Director, Regulatory – Scientific Affairs

CTI Clinical Trial and Consulting Services

full-time

Posted on:

Location Type: Remote

Location: Kentucky • United States

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Job Level

Senior

About the role

  • 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.

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
Benefits
  • Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow.
  • 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.
  • 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.
  • Encourage care for the world around us through our unique CTI Cares program.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyclinical developmentregulatory risk mitigationprotocol designendpoint selectionsafety strategyregulatory intelligencetechnical document preparationregulatory agency interactionICH Good Clinical Practice
Soft Skills
strategic guidancecommunicationcollaborationleadershipmentoringadvisingproblem-solvingexpert knowledgescientific expertisethought leadership
Certifications
MDPharmDPhDmaster’s Level advanced scientific degree