Senior Director Regulatory Affairs
Senior Director, Regulatory Affairs
Location: Hybrid (California-based preferred; travel to SF Bay Area 1x/month)
Industry: Biotech - Allogeneic Cell Therapy for Autoimmune Disorders
Client Type: Clinical-stage biotech (small team, VC-backed)
Salary: $210,000 - $280,000 annually + bonus + equity
About the Client
Our client is a clinical-stage biotech developing off-the-shelf regulatory T cell therapies to restore immune tolerance in chronic autoimmune diseases. Their lead program targets refractory lupus nephritis using engineered Tregs with enhanced homing and persistence. With strong scientific leadership and investor backing, they're building a lean, execution-focused team to advance their pipeline through early clinical development.
The Opportunity
We're supporting our client in hiring a Senior Director of Regulatory Affairs to lead global regulatory strategy and operations. You'll be the regulatory lead across programs-driving IND and CTA submissions, interfacing with health authorities, and helping build internal systems from the ground up.
This is a strategic and hands-on role. If you've worked on INDs, enjoy translating science into strategy, and want to be part of a small, mission-driven team-this could be a great fit.
Key Responsibilities
- Lead global regulatory strategy for the pipeline, starting with the lead allogeneic Treg program
- Drive IND preparation, submission, and maintenance; oversee CTA filings for ex-US trials
- Serve as primary liaison with FDA and global health authorities; lead regulatory meetings and correspondence
- Partner cross-functionally with Clinical, CMC, and Nonclinical teams
- Stay ahead of evolving cell therapy guidance and adjust strategy accordingly
- Help build internal regulatory systems, SOPs, and documentation workflows
- Manage external regulatory consultants and vendors
Qualifications
- Experience in biotech/pharma regulatory affairs (cell/gene therapy a plus)
- Familiarity with INDs and early-stage development strategy
- Strong scientific literacy-comfortable engaging with immunology, cell engineering, and translational data
- Clear communicator, collaborative mindset, and comfortable in a lean, fast-paced environment
- Must be based in California or able to travel to SF Bay Area monthly
Bonus
- Experience with allogeneic cell therapies or autoimmune indications
- Prior work in a startup or small biotech setting
- Familiarity with regulatory requirements for genetically modified cell products
Apply confidentially to learn more.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.