Manager, Regulatory Affairs
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
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.