Job Description

Senior Manager, Regulatory Affairs

Location: San Rafael, CA (Hybrid) | Open to Remote

9-Month Assignment (Potential to Extend)

Pay: $70-75/hour

Our client a global leader specializing in therapeutics for rare genetic diseases, is seeking a Sr. Manager, Regulatory Affairs to join their team. The Senior Manager, Regulatory Affairs will play a key role in developing and executing global regulatory strategies throughout a program's lifecycle. This includes preparing for Health Authority (HA) interactions, overseeing regulatory submissions, and ensuring compliance with global regulatory requirements. The Regulatory Nonclinical/Clinical (RNC) team leads the strategy for nonclinical and clinical regulatory pathways, playing a critical role in regulatory filings, approvals, and post-approval maintenance.

Key Responsibilities:

Regulatory Strategy & Planning

• Support the development and execution of nonclinical/clinical regulatory strategies
• Participate in Study Execution Teams, identifying key regulatory considerations
• Collaborate with CROs for global clinical trial regulatory submissions and HA interactions
• Assist in HA meeting preparation, submission planning, and execution
• Maintain INDs, CTAs, NDAs, and BLAs throughout the product lifecycle

Regulatory Submissions & Compliance

• Develop and coordinate core nonclinical/clinical content for regulatory submissions
• Ensure high-quality, compliant submissions adhering to global regulatory guidelines
• Lead the preparation of submission packages, including:
• Protocols
• Clinical Study Reports
• Briefing Books
• Annual Reports
• Collaborate with Regulatory Operations & Project Management to align submission timelines and quality-control processes
• Maintain and archive all HA submissions and correspondence

Cross-Functional Collaboration & Leadership

• Work in a cross-functional environment with Regulatory, Clinical, and Nonclinical teams
• Stay up-to-date on regulatory trends, laws, and guidelines
• Attend and contribute to functional and project team meetings
• Communicate key regulatory updates to senior leadership and internal teams

Required Skills & Experience:

• Decision Making & Problem Solving – Ability to identify issues, engage stakeholders, and drive solutions
• Strategic Thinking & Planning – Anticipate risks and opportunities, develop long-term regulatory plans
• Cross-Functional Collaboration – Work effectively across Regulatory, Clinical, and Nonclinical teams
• Regulatory Strategy & Frameworks – Deep understanding of drug development, regulatory pathways, and global submission processes
• Health Authority Engagement – Experience in preparing and executing HA meetings and submissions
• Scientific Writing – Strong technical writing skills for regulatory submissions (CTAs, NDAs, BLAs, Annual Reports, etc.)
• Drug Development & Study Design – Knowledge of how nonclinical and clinical studies fit into overall regulatory objectives

Education & Qualifications:

• Ph.D. in health/life sciences (preferred) | Master’s or Bachelor’s degree with relevant experience acceptable
• 6+ years of experience with a Ph.D. | 8+ years with a Master’s or Bachelor's degree
• Regulatory Affairs experience in Nonclinical/Clinical drug development preferred
• 0-1 year of line management experience preferred

Please submit your resume in Word or PDF format to be considered

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