Regulatory Manager

Overview

The Regulatory Manager provides regulatory development advice and guidance for the optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.

What you'll do

• Provide regulatory guidance throughout the clinical development life cycle.
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications, and provide strategic regulatory input as required.
• Develop and/or review documents intended for submission to Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with external and internal customers and at business development meetings.
• Work within a project team and, where necessary, lead the project for the region or globally.
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
• Maintain project plans, project trackers and regulatory intelligence tools as they pertain to assigned responsibilities, and keep Regulatory Leadership updated.
• Assist in the development of Regulatory Affairs Specialists and other operational area staff, as required.
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities.
• Assist in establishing company standards to ensure the highest quality of submitted information.
• Participate in maintaining and executing corporate quality initiatives across business units within clinical solutions.
• Keep abreast of and continually expand knowledge of laws, regulations and guidelines governing drug development and approval.
• Provide ICH GCP guidance, advice and training to internal and external clients.

What you'll need

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
• Computer literacy (MS Office / Office 365).
• Fluent in English.
• 5+ years or more of relevant regulatory affairs experience.
• Informed knowledge of all aspects of the drug development process, inclusive of regulatory milestones.
• Specialized knowledge of regulatory activities for at least one major region (EU, US), including submissions to Regulatory Authorities such as INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
• Ability to understand clinical and pre-clinical study results and help interpret them for regulatory positions and strategy.
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
• Availability for domestic and international travel, including overnight stays.

Nice to have

• Graduate or postgraduate degree.
• Basic understanding of financial management.

Details

• Remote, United States.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.