The company
A growing biotech preparing for its next inflection point.
Our client is a privately backed preclinical biotechnology company in Paris. Its focused platform addresses serious diseases where existing treatment options remain limited. With the lead program advancing and key development decisions ahead, the company is building the regulatory operating model required for first-in-human development.
This is the first senior regulatory appointment. The Regulatory Lead will work directly with scientific and executive leadership, bringing structure, judgment, and external credibility to the development path.
The mandate
What you will own.
- Own the global regulatory strategy for the lead program from late preclinical development through first-in-human readiness
- Translate scientific, nonclinical, CMC, and early clinical plans into one coherent regulatory path
- Lead agency interaction planning across Europe and the United States, including scientific advice and pre-submission meetings
- Shape the CTA and IND content plan, submission sequence, and evidence requirements with internal teams and external partners
- Select and manage specialist regulatory consultants while building the internal regulatory capability
- Bring clear regulatory judgment to portfolio, development, and investment decisions
Your evidence
What will make you credible.
- Senior regulatory experience in biotechnology or biopharma, ideally within an emerging company environment
- Direct involvement in taking an innovative program from preclinical development toward CTA or IND submission
- Strong understanding of the interface between nonclinical, CMC, clinical, and regulatory strategy
- Confidence working with senior scientists, executives, board members, and external development partners
- Fluent professional English. French is valuable but not essential
You will not inherit a finished playbook. You will create the regulatory logic that connects the science, the development plan, and the decisions that determine whether the program can move forward.
Confidential process
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