Associate Director Regulatory Affairs
Associate Director / Director Regulatory Affairs
Confidential Early‑Stage Biotech | San Diego, CA (Onsite Preferred / Hybrid Considered)
Expected Compensation: $180-$200k base + bonus + equity
We're supporting a confidential, venture‑backed RNA therapeutics company in San Diego. They're backed by top-tier global biotech investors, and developing a pipeline showing promise in multiple therapeutic areas.
This is the company's first in‑house regulatory hire, representing a rare chance to step into real ownership at the Associate Director or Director level. You'll work directly with an experienced leadership team (with deep RNA development expertise from prior roles at leading RNA companies) to drive IND‑enabling work, lead FDA interactions, and build scalable regulatory infrastructure.
What You'll Own
- Serve as the primary regulatory point of contact across early‑stage programs.
- Lead IND planning, authorship, coordination, and submission readiness.
- Drive FDA meeting preparation and execution in collaboration with senior leadership.
- Establish regulatory processes, templates, vendor oversight, and cross‑functional alignment.
- Integrate CMC, nonclinical, and clinical components into cohesive regulatory packages.
What We're Looking For
- 8-10+ years in Regulatory Affairs (experience with RNA-based therapies preferred).
- Hands-on involvement in IND submissions and FDA interactions.
- Strong communicator with confidence presenting to Health Authorities and executives.
- Comfortable operating in a lean, high-growth, science-driven environment.
- Ability to be onsite in San Diego several days per week.
Why This Role
- High visibility, high ownership. You own the regulatory function.
- Direct access to scientific and executive leadership.
- Broad scope that accelerates your path toward future Head/VP progression.
- Mission-driven pipeline targeting severe, underserved diseases with promising early data.
Not sure you hit every requirement?
If you have a strong regulatory foundation and can confidently lead FDA interactions, include a brief note on why you believe you'd excel in this role. AI use is not prohibited but we'd love to hear from YOU.
FAQs
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