About the Company:
I'm working with a dynamic, fast-growing Biotech company that is expanding its regulatory affairs team. With a strong presence across several major U.S. markets, the company is dedicated to advancing its projects while making a positive impact on consumer health.
Key Responsibilities:
- Collaborate effectively with cross-functional teams and global/regional stakeholders to ensure alignment and clear communication.
- Review reports, investigator brochures (IBs), and other safety-related documents to ensure accuracy, consistency, and completeness.
- Oversee regulatory operations, including the preparation and submission of documentation
What We're Looking For:
- 5+ years experience regulatory affairs, or project management
- Bachelor's degree in biological or healthcare science.
- Experience managing development, submission, and approval activities in different regions globally.
- Experience with clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.