Job Description

Manager, Regulatory Affairs

Pay: $60-63/hour

6-Month Assignment (Potential to Extend)

Location: Hybrid in San Rafael, CA (Open to remote)

Our client, a leading global biotech company dedicated to delivering innovative therapeutics for patients with serious and life-threatening rare genetic diseases, is seeking a Manager, Regulatory Affairs to join their team!

In this role, you will play a critical part in regulatory strategy , guiding program teams in interpreting regulatory legislation and supporting the execution of global nonclinical/clinical regulatory strategies.

Key Responsibilities:

• Assist in developing nonclinical/clinical regulatory strategies throughout a program’s lifecycle
• Provide guidance on regulatory legislation and best practices
• Support regulatory planning, document preparation, and health authority (HA) interactions
• Collaborate with CROs, internal teams, and regulatory operations to manage submissions
• Maintain IND/CTAs , including annual reports and regulatory documentation
• Prepare submission packages (e.g., protocols, annual reports, briefing books)
• Ensure high-quality documentation that aligns with regulatory guidelines
• Contribute to product lifecycle maintenance regulatory submissions
• Stay up to date on regulatory policies, trends, and guidelines

Education & Qualifications:

• Degree in Life Sciences (Chemistry, Molecular Biology, etc.) – PhD preferred (Master’s/Bachelor’s with experience accepted)
• 4+ years of experience with PhD | 6+ years with Master’s/Bachelor’s
• Experience in Regulatory Affairs (Nonclinical/Clinical preferred)
• Strong problem-solving, leadership, and communication skills
• Ability to collaborate cross-functionally and influence key stakeholders
• Knowledge of global regulatory frameworks, submission processes, and drug development stages
• Experience in scientific writing for regulatory submissions

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

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