Job Details

Regulatory Affairs Manager

6-Month Assignment (Potential to Extend)
Target Start Date: January 5, 2026
100% Remote
Pay: up to $75/hour

About the Company & Department

The Client is a leading innovator in the development of therapies across the product lifecycle, with a strong focus on advancing programs from early research through global commercialization. The Global Regulatory Affairs (GRA) organization plays a critical role in this mission by securing and maintaining regulatory approvals for new and existing products.

GRA serves as the primary interface between regulatory authorities and internal development teams. The department ensures that product plans are aligned with regulatory expectations, stays current with evolving legislation and guidance, and advises teams on how best to interpret regulatory requirements.

Within GRA, the Regulatory Affairs Nonclinical/Clinical (RNC) team leads the development and execution of regulatory strategies for nonclinical and clinical programs. This team prepares key components of global submissions and manages Health Authority (HA) interactions before, during, and after major regulatory milestones.

About the Role

The Regulatory Affairs Manager supports global nonclinical and clinical regulatory strategy across multiple programs. The role is responsible for executing delegated regulatory activities, contributing to regulatory documentation, supporting Health Authority interactions, and helping maintain global submissions throughout the product lifecycle.

This position works cross-functionally with regulatory, clinical, nonclinical, and operations teams, and plays an important part in ensuring high-quality, compliant, and timely regulatory submissions.

Key Responsibilities

Development-Stage Programs

• Support development of nonclinical and clinical regulatory strategies and plans.
• Assist with planning, documentation, and logistics for Health Authority meetings/interactions.
• Participate in Study Execution Teams to identify regulatory considerations and communicate them to the RNC Lead.
• Partner with CROs supporting regulatory submissions and HA interactions for global clinical trials.
• Draft and coordinate nonclinical/clinical content for global regulatory submissions with oversight from the RNC Lead.
• Ensure submission content meets quality standards and complies with applicable regulatory guidance.
• Lead maintenance of INDs/CTAs, including annual reports and ongoing study documentation.
• Compile materials for HA submission packages (protocols, briefing documents, annual reports, regulatory forms).
• Align submission timelines with Regulatory Project Management and ensure accurate timeline tracking.
• Collaborate with Regulatory Operations to finalize documents and review QC'd published outputs.
• Maintain administrative, nonclinical, and clinical components of INDs, NDAs, and BLAs.
• Oversee archiving of HA submissions and regulatory correspondence.

• Lead updates to clinical and nonclinical sections of core dossiers for international marketing applications.
• Support lifecycle maintenance submissions, including supplements, renewals, and annual reports.
• Coordinate with international regulatory teams on global filings, agency interactions, and response packages.

• Participate in cross-functional and functional area meetings.
• Stay current on relevant global regulations, policies, and guidelines.
• Review SOPs, study protocols, and study reports as needed.
• Ensure regulatory project trackers and timelines accurately reflect planned submissions.

• Degree in a life or health science discipline (e.g., biology, chemistry, molecular biology).
  
  • PhD preferred; Master's/Bachelor's accepted with relevant experience.
• 4+ years of regulatory experience, preferably in nonclinical/clinical regulatory affairs.
• Experience supporting regulatory submissions (INDs/CTAs, supplements, global filings) preferred.
• Knowledge of global regulatory guidelines and Health Authority expectations.
• Strong organizational skills with the ability to manage timelines and multiple deliverables.
• Excellent communication skills and ability to work cross-functionally.