Manager/Senior Manager- US Regulatory Lead and Regulatory Operations

About COUR

COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR’s platform of immune-modifying nanoparticles aims to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression.

About The Role

This individual will be responsible for ensuring compliance with regulatory standards while driving the US regulatory strategy for product(s)/project(s) ensuring there is sound regulatory foundation for the successful optimization of the product/project in accordance with business priorities. This role will work closely with the Head of Regulatory Affairs and cross-functional stakeholders (e.g., program management, clinical operations, clinical development, and technical operations) ensuring alignment on US strategy and compliance with regulatory requirements on product(s) and project(s).

What You'll Do

• Implement regulatory strategies for assigned products, considering US regulations and global requirements.
• Identify and assess regulatory risks and develop mitigation strategies.
• Ensure product compliance with applicable US regulations throughout the product lifecycle including authorship of routine regulatory correspondence (e.g. annual reports, investigator packages).
• Identify and resolve issues affecting submission timelines; drive process efficiency and ensure high-quality, timely submissions.
• Prepare and manage regulatory packages and submissions, including original and amendment filings for INDs. Coordinate collection of functional documents in support of regulatory applications.
• Maintain regulatory and technical sections of CTD filings to ensure compliance and archives with current product information (applications, letters, etc.).
• Collaborate with CROs/partners to support site initiation, as applicable.
• Develop and maintain expertise in relevant US regulations and guidelines.
• Support process improvement initiatives, standards development, and metrics for COUR Regulatory Information Management System.
  
  

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5-7+ years of progressively responsible experience in Regulatory Affairs.
• Strong knowledge of regulatory business operations, budgeting, and vendor/contract management.
• Proficient in Microsoft Excel and regulatory and contract management platforms; experience with Regulatory Information Management System preferred.
• Competencies: Teamwork & Collaboration, Attention to Detail, Negotiation skills, Problem Solving, Organizational skills, Written and Verbal Communications
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations.
• This is a hybrid/remote role.