Regulatory Affairs Expert

A clinical-stage biotech is looking to hire a Regulatory Affairs Expert on a part-time contract basis.

Applicants must have extensive experience in Phase II-III neuropsychiatry trials, and will ideally also have experience in rare neurodevelopmental disorders. Comprehensive direct involvement in dealing with the EMA and FDA is also required.

Clinical Development Experience

• Phase II–III Trial Design: Proven track record in designing clinical protocols, defining endpoints, inclusion/exclusion criteria, sample sizes, and using psychiatric scales/biomarkers.
• Development Strategy: Ability to align trial design with global regulatory strategy and registration goals in both the U.S. and EU.
• Risk Management: Anticipating regulatory objections and incorporating appropriate safety and efficacy measures for psychiatric indications.

FDA and Regulatory Interactions

• Dossier Preparation and Defense: Hands-on experience with INDs, briefing packages, end-of-phase II meetings, and pre-NDA meetings with the FDA.
• Regulatory Negotiation: Skilled in negotiating primary endpoints, statistical analysis plans, and addressing FDA Information Requests.
• Global Perspective: Knowledge of EMA and other key regulatory agencies to shape global approval strategies.

For additional information, and a confidential discussion, please apply now with an updated CV.