Associate Director, Regulatory Affairs

Role Summary

Associate Director, Regulatory Affairs. Responsible for performing and managing key regulatory activities compliant with US, ex-US, and company standards. Act as regulatory lead on project teams, providing regulatory guidance and oversight, and contribute to regulatory affairs initiatives to improve internal standards and systems.

Responsibilities

• Act as the primary regulatory representative on and provide strategic regulatory guidance to project teams and sub-teams. Proactively define and assess regulatory risks associated with product development for assigned products
• Lead the planning and preparation of global regulatory submissions (eg, INDs, CTAs, meeting requests, investigation plans, responses to health authorities)
• Serve as the liaison between the company and regulatory agencies for assigned projects
• Prepare regulatory development plans for assigned projects
• Maintain active INDs/CTAs (amendments and annual reports)
• Develop and maintain regulatory knowledge of US, EU and ROW regulations
• Perform literature searches, prepare special reports and assemble documentation to support project teams
• Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
• Participate in initiatives aimed at improving internal departmental standards and systems

Qualifications

• Minimum of 6+ years’ experience in a biotech and/or pharmaceutical environment, including 4+ years in Regulatory Affairs
• Minimum requirement of a bachelor’s degree in a scientific discipline or equivalent
• Experience in neuroscience therapeutic areas preferred
• Team player that can handle multiple tasks simultaneously in a fast-growing company
• Possess outstanding verbal and written communication skills
• Requires a highly motivated, resourceful, creative individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
• Excellent organizational skills and attention to detail

Skills

• Regulatory strategy and submissions
• Liaison with regulatory agencies
• Regulatory development planning
• Knowledge of US, EU and ROW regulations
• Cross-functional collaboration

Education

• Bachelor’s degree in a scientific discipline or equivalent

Additional Requirements

• Remote role based in the US, with occasional travel (10% - 15%)