Job Description Vice President, Regulatory Affairs Role Overview We are searching for an innovative regulatory expert to spearhead our mission in revolutionizing mental health treatment.
This pivotal role will involve guiding regulatory pathways for novel neuropsychiatric therapies, driving their journey from conception through to market release.
Working closely with executive leadership and regulatory teams, the Vice President of Regulatory Affairs will shape strategies to ensure all regulatory requirements are met, while advancing our position as a trailblazer in psychiatric care.
Key Responsibilities Strategic Regulatory Leadership : Develop and execute comprehensive regulatory plans, alongside any future projects.
Collaborate with the CMO, COO, and key executives to align strategies with clinical objectives and business goals.
Regulatory Submissions and Agency Interaction : Oversee submissions to the U.S. FDA (IND, NDA) and EMA (CTA, MAA), ensuring rigorous scientific quality across nonclinical, clinical, CMC, and device components while maintaining regulatory compliance and meeting project timelines.
Cross-Functional Guidance : Provide expert guidance on regulatory standards across all drug development phases, coordinating technical input and reviewing documents for regulatory submissions.
Leadership and Team Development : Mentor and empower cross-functional teams on regulatory processes, fostering a high-performance culture that supports company-wide excellence.
Communication and Issue Resolution : Keep executive stakeholders updated on regulatory progress and timelines, escalating challenges as necessary for timely resolution.
Regulatory Function Growth : Work with the CMO and COO to expand our Regulatory Affairs capabilities, adapting team roles as programs advance through the development pipeline.
Industry Advocacy : Act as the company's voice at regulatory meetings, conferences, and industry forums to promote our strategies and regulatory positions.
Candidate Profile The ideal candidate will be a seasoned regulatory leader with a deep understanding of global regulatory frameworks and hands-on experience in end-to-end regulatory strategy execution for complex clinical programs.
Qualifications Education : A degree in a Life Sciences field, such as biology, biochemistry, pharmacy, or engineering.
Experience : 20+ years in regulatory affairs within the biotech or pharmaceutical industry, including senior roles with success in IND, NDA (U.S.), CTA, and MAA (EU) submissions.
Therapeutic Expertise : Strongly preferred experience in CNS or psychiatric drug development, with familiarity in working with the FDA's Office of Neuroscience - Division of Psychiatry.
Combination Product Knowledge : Background in regulatory support for drug-device combination products is a significant asset.
Operational Expertise : Proven ability to manage timelines, budgets, and resources, including working with external regulatory vendors.
Regulatory Compliance : Extensive experience working in GxP-regulated environments, with up-to-date knowledge of ICH guidelines, SOPs, and industry standards.
Additional Skills : Experience with REMS program implementation and prior regulatory agency experience are highly advantageous.
Personal Attributes Passionate and Visionary : Dedicated to shaping the future of psychiatric and neurological treatments.
Hands-On Leadership Style : Strong team collaborator who thrives in a cross-functional setting with effective communication skills.
Analytical and Detail-Oriented : High-level expertise in scientific and regulatory analysis, with exceptional regulatory writing skills.
#LI-OG1