Job Details

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.