Associate Director, Regulatory Affairs

Role Summary

The Associate Director, Regulatory Affairs is responsible for performing and managing key regulatory activities that are compliant with US, ex-US, and company standards. Reporting to the Executive Director, Regulatory Affairs, you will act as the regulatory lead on project teams, providing regulatory guidance and oversight. You will also contribute to regulatory affairs initiatives aimed at improving 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

Additional Requirements

• Travel: occasional travel (10% - 15%)