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Position Summary:
- Provides regulatory development advice and guidance for clinical trials and ensures timely quality regulatory submissions.
- Maintains current knowledge of regulations and provides analysis to project teams.
Key Responsibilities:
- Compiles, coordinates, and reviews submissions to regulatory authorities, including CTA/IND and annual reports.
- Serves as representative of Global Regulatory Affairs at project team and business development meetings.
- Oversees Regulatory Affairs Specialists to achieve submission targets.
Qualifications:
- Requires a bachelor's degree and 5+ years of regulatory affairs experience.
- Knowledge of drug development process and regulatory milestones for at least one major region (EU, US).
- Strong interpersonal and communication skills with ability to manage multiple tasks.
Compensation & Benefits:
- Salary range $106,000 - $151,000 USD annually.
- Eligible for discretionary annual bonus and a comprehensive benefits package.
- Remote, United States position.
Precision Medicine Group
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.