GQR
Overview
A clinical-stage neuroscience biotechnology company is seeking a seasoned regulatory leader to join its team. The organization is advancing a pipeline of small molecules targeting novel mechanisms across a range of neuropsychiatric and neurodevelopment indications. Key Responsibilities
Design and implement comprehensive global regulatory strategies that align with corporate objectives and meet FDA and EMA standards. Lead all regulatory agency engagements, including the planning and execution of milestone meetings (e.g., pre-IND, End-of-Phase 2, Scientific Advice). Direct the preparation, submission, and lifecycle management of regulatory documentation, such as INDs, CTAs, briefing packages, and expedited program requests (e.g., Orphan Drug, Fast Track, Breakthrough). Provide expert guidance on clinical development strategies, regulatory pathways, risk assessment, and data requirements to support program advancement. Partner cross-functionally with Clinical, CMC, Nonclinical, and Quality teams to ensure regulatory consistency and timely deliverables across all development activities. Maintain up-to-date knowledge of regulatory trends, evolving guidelines, and policy changes in neuropsychiatry and CNS therapeutic areas. Key Qualifications
Advanced degree (PhD, PharmD, MD, or MSc) in life sciences or a related discipline. At least 10 years of experience in regulatory affairs or regulatory science within the biotechnology or pharmaceutical industry, including direct engagement with FDA and EMA. Demonstrated success leading CNS or neuropsychiatry programs from IND/CTA through mid- to late-stage clinical development. Deep understanding of global regulatory frameworks, including FDA, EMA, and ICH guidelines. Prior experience in a startup or emerging biotech environment is strongly preferred. Strong scientific acumen, excellent communication skills, and the ability to operate effectively at both strategic and tactical levels. Seniority level
Executive Employment type
Full-time Job function
Research and Science
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A clinical-stage neuroscience biotechnology company is seeking a seasoned regulatory leader to join its team. The organization is advancing a pipeline of small molecules targeting novel mechanisms across a range of neuropsychiatric and neurodevelopment indications. Key Responsibilities
Design and implement comprehensive global regulatory strategies that align with corporate objectives and meet FDA and EMA standards. Lead all regulatory agency engagements, including the planning and execution of milestone meetings (e.g., pre-IND, End-of-Phase 2, Scientific Advice). Direct the preparation, submission, and lifecycle management of regulatory documentation, such as INDs, CTAs, briefing packages, and expedited program requests (e.g., Orphan Drug, Fast Track, Breakthrough). Provide expert guidance on clinical development strategies, regulatory pathways, risk assessment, and data requirements to support program advancement. Partner cross-functionally with Clinical, CMC, Nonclinical, and Quality teams to ensure regulatory consistency and timely deliverables across all development activities. Maintain up-to-date knowledge of regulatory trends, evolving guidelines, and policy changes in neuropsychiatry and CNS therapeutic areas. Key Qualifications
Advanced degree (PhD, PharmD, MD, or MSc) in life sciences or a related discipline. At least 10 years of experience in regulatory affairs or regulatory science within the biotechnology or pharmaceutical industry, including direct engagement with FDA and EMA. Demonstrated success leading CNS or neuropsychiatry programs from IND/CTA through mid- to late-stage clinical development. Deep understanding of global regulatory frameworks, including FDA, EMA, and ICH guidelines. Prior experience in a startup or emerging biotech environment is strongly preferred. Strong scientific acumen, excellent communication skills, and the ability to operate effectively at both strategic and tactical levels. Seniority level
Executive Employment type
Full-time Job function
Research and Science
#J-18808-Ljbffr