Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing regulatory strategies from early development through late-stage clinical programs. The role involves direct interaction with the FDA and global regulatory agencies, leading submissions, and providing regulatory guidance across functional teams.
Serve as the primary contact with FDA and other regulatory agencies, preparing for and leading agency meetings.
Lead the preparation and submission of domestic and global regulatory documents (e.g., IND, CTA, NDA/MAA) and manage response strategies to regulatory inquiries.
Prepare and maintain regulatory submissions, ensuring compliance with FDA and global health authority requirements.
Provide interpretation, guidance, and training on global regulations to internal teams, identifying regulatory opportunities and risks.
Pursue special and expedited review designations as appropriate for development programs.
Bachelor’s degree in a relevant field; advanced degree preferred.
10+ years of experience in the pharmaceutical/biotechnology industry, with at least 5 years in Regulatory Affairs.
Experience in key areas of regulatory affairs, including strategy development, global submissions, agency meetings, and expedited designations; CMC experience is a plus.
Experience in ophthalmology is an advantage.
Project management experience is beneficial.
Strong oral and written communication skills.
Comprehensive understanding of global pharmaceutical development, including clinical and nonclinical activities.
Department: Direct Clients
This is a full time position
Job Details Description Baptist Health Urgent Care is looking for a Medical Office Team Leader (Center Manager) to join our team in Little Rock, AR. The ideal candidate will have previous experience in a healthcare office and enjoy participating in both daily operations...
Sephora in San Antonio seeks a part-time Beauty Advisor to deliver personalized beauty experiences and drive sales. The role requires previous experience in a retail or client-focused environment, excellent communication skills, and a passion for beauty. Compensation ranges...
...your career alongside exceptional peers. Job Summary As a Python Developer at Aretum, you will contribute to the design, development,... ...development. Requirements ~3+ years of solid Python and Django development experience ~ Experience with ETL processes to...
...least 3 days per week. This position is hybrid Onsite 3 days and Remote 2 days. Candidates need to be local in or near Chicago, IL.... ...Expert knowledge of SEO Best Practices. -Vast experience managing PPC Campaigns. -Excellent time management. Benefits include...
...Responsibilities: Maintain all Data Management project documentation in an audit-ready manner. Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved. Oversee Data Management activities from study start...