RA Consultant - Contract - San Francisco
Ready to advance precision in the world of biotech? Join our client's cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow's breakthroughs.
探花合集 is seeking an Associate Director or Director of Regulatory Affairs for a temp-to-perm opportunity.
Primary Responsibilities:
In this role, you will play a pivotal part in developing and executing global regulatory strategies for clinical development programs, with a focus on virology assets. This position is ideal for a hands-on regulatory professional who thrives in a fast-paced, collaborative environment and is open to transitioning into a permanent role.
Skills & Requirements:
- Advanced degree in life sciences or a related field (PhD, PharmD, MD preferred; MS with strong experience considered).
- Experience in Regulatory Affairs within biotech or pharmaceutical industries.
- Proven expertise in clinical-stage regulatory submissions.
- Strong knowledge of FDA and EMA regulatory frameworks.
- Ability to work independently while effectively collaborating across teams.
- Excellent written and verbal communication skills.
The Research Scientist's responsibilities will be:
- Develop and implement global regulatory strategies aligned with clinical development plans.
- Lead the preparation, review, and submission of regulatory filings, including IND/CTA amendments and briefing packages.
- Act as the primary regulatory contact for health authority interactions and meetings.
- Provide regulatory guidance to cross-functional teams, including Clinical, CMC, Nonclinical, and Quality teams.
- Monitor regulatory intelligence and assess its impact on development programs.
- Support regulatory aspects of clinical trial execution and lifecycle management.
- Manage external vendors and consultants as needed.
- Ensure compliance with applicable global regulations and guidelines.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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