Senior Manager, Regulatory Affairs
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