Responsibilities:

• Oversee Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs) and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
• Coordinate the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
• Work closely with project management to mitigate/resolve issues and/or deviations from target timelines.
• Supervise and manage Regulatory Team staff members, as assigned.
• Lead and participate in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
• Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
• Coordinate the maintenance of work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, trackers, etc.
• Perform literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
• Provide project management support for projects as needed.
• Coordinate across projects as needed to ensure harmonization and knowledge sharing.
• Provide oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.

Requirements:

• Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
• Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
• Superior organizational skills and customer service abilities.
• Ability to analyze medical research data and review experimental protocols.
• Strong working knowledge of Microsoft office; experience with SharePoint a plus.
• Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
• Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
• Ph.D. or M.S. or equivalent with related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, regulatory affairs, or other applicable field
• 3+ years

Job Snapshot