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Position Summary:
- Provides regulatory development advice and guidance.
- Prepares regulatory submissions in compliance with applicable regulations.
- Maintains a current knowledge of regulations and guidance documents.
Essential Functions:
- Compiles and coordinates applications to Regulatory Authorities.
- Develops and reviews documents for submission.
- Serves as representative at project team meetings.
Qualifications:
- Bachelors degree in a scientific or healthcare discipline.
- 5+ years of relevant regulatory affairs experience.
- Knowledgeable of clinical trials methodology.
Competencies:
- Strong interpersonal skills and ability to contribute to a team environment.
- Ability to manage multiple tasks in a fast-moving environment.
- Exhibits high self-motivation.
Precision Medicine Group
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.