Regulatory Affairs Consultant, Regulatory Strategy - Remote

Overview

The Regulatory Affairs Consultant, Regulatory Strategy, is responsible for guiding clients through regulatory processes, particularly in clinical development and application filings. The role coordinates meetings, guides authors, and may serve as primary point of contact with regulatory agencies for clients.

In Short

• Guide clients on decisions, agency meetings, and regulatory filings, with emphasis on clinical development.
• Oversee INDs, CTAs, application filings, and approvals for various clients.
• Handle FDA meetings, prepare clients, resolve questions, and develop/execute data driven strategies.
• Engage in multiple phases of drug development, ensuring client needs are met.
• Develop and review regulatory documents, authoring NDA, BLA submissions.
• Manage and submit forms and documents globally, ensuring compliance.
• Lead meetings with FDA representatives and assist clients in navigating regulatory requirements.
• Conduct research, provide regulatory advice, and support marketing initiatives.
• Mentor and train new employees on regulatory processes.
• Collaborate across departments and maintain continuous education on regulatory updates.

Requirements

• Bachelor’s degree in a scientific field, Master’s preferred.
• 6+ years in regulatory affairs, including agency interactions and project management.
• Experience in filing INDs/CTAs and NDAs/BLA/MAAs.
• Expertise across all phases of drug development.
• Strong research skills and knowledge of FDA regulations.
• Strong communication skills to mentor and influence stakeholders.
• Ability to manage multiple projects in a fast-paced environment.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings and ongoing recognition opportunities.
• Flexible paid time off program and company paid holidays.
• Flexible working hours and fully remote work options.