Senior Nonclinical Regulatory Strategist & Submission Author

Remote

Compensation: $100-130/hr

12-month contract to start

ABOUT THE ROLE

Our client is seeking a Senior Nonclinical Regulatory Strategist & Submission Author for a remote, 12-month contract position. In this role, you will be responsible for preparing, authoring, and managing nonclinical content for a variety of regulatory submissions, including clinical trial applications, amendments, and global registration dossiers (CTD Modules 1, 2, and 4) for the U.S., EU, and other international regions. You will support the full product lifecycle, from development through post-approval, by maintaining annual and safety update reports, authoring post-approval submissions, and developing global nonclinical regulatory strategies. The position also involves responding to Health Authority queries, conducting inspection-readiness and vendor qualification audits, ensuring compliance with evolving regulatory requirements, and serving as a technical liaison to clients. You will play a key role in project management, client relationship management, and quality control of regulatory documentation.

WHAT YOU'LL DO

• Prepare and manage nonclinical content for clinical trial applications and regulatory amendments
• Author nonclinical sections (CTD Modules 1, 2, and 4) of registration dossiers for global submissions, including INDs, NDAs, BLAs, JNDA, IRDs, and other international marketing applications
• Prepare and maintain Annual Reports (e.g., IND, NDA, Canada YBPR) and Development Safety Update Reports (DSURs)
• Author post-approval submissions, including Supplements, Variations, Renewals, and compliance assessments
• Utilize nonclinical templates and source documentation to develop reports supporting clinical trial applications, registration dossiers, annual reports, and post-approval submissions
• Prepare, update, and maintain nonclinical sections of Marketing Applications and Marketing Authorizations
• Develop and execute global nonclinical regulatory strategies supporting product development and post-approval lifecycle management
• Prepare responses to Health Authority questions, deficiency letters, and requests for nonclinical data
• Perform inspection-readiness audits of client and vendor facilities, and conduct vendor qualification audits and/or nonclinical study monitoring on behalf of clients
• Maintain up-to-date knowledge of evolving global nonclinical regulatory requirements and guidelines
• Serve as a technical liaison with clients, providing guidance on submission content, regulatory strategy, and timelines
• Support project management and client relationship management activities, including coordination across internal and external stakeholders
• Review and verify nonclinical sections prepared by internal teams or clients against validated source documentation
• Conduct dossier conversions for legacy submissions, including mapping content to CTD format, correcting formatting, identifying data gaps, and developing scientific justifications as needed
• Perform quality control checks, including formatting verification, proofreading, transcription accuracy, and OCR validation prior to dossier finalization

WHAT YOU BRING

• Minimum of 7 years of experience in nonclinical regulatory affairs; leadership and project management experience strongly preferred
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology, or related field); advanced degree preferred
• In-depth knowledge of global nonclinical regulatory requirements and CTD structure (Modules 1, 2, and 4)
• Strong understanding of pharmaceutical sciences and drug development processes
• Demonstrated expertise in regulatory and technical writing
• Excellent written and verbal communication skills
• Proven ability to manage multiple projects, competing priorities, and aggressive timelines
• Experience interacting with global Health Authorities and a solid understanding of their nonclinical expectations