Manager, Regulatory Clinical Applications

As the Manager, Regulatory Clinical Applications, you will play a key role in supporting the planning and execution of clinical trial application (CTA) activities across global studies.

Requirements

• Bachelor's degree in life sciences or related field required; advanced degree preferred.
• 5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry.
• Familiarity with CRO operations and global regulatory requirements for clinical trial applications.
• Experience supporting global interventional clinical studies and managing CTA submissions.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Knowledge of GxP, ICH guidelines, and health authority regulations.
• Effective communication and interpersonal skills; ability to work collaboratively across teams.
• Detail-oriented with strong analytical and problem-solving capabilities.
• Proficiency in project management and documentation systems.