Manager, Regulatory Affairs

📋 Description

• Lead and coordinate regulatory and ethics committee submissions and maintain required approvals
• Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained in
• Provide expert regulatory guidance throughout clinical research projects and advise stakeholders on
• Review and provide recommendations on technical and study documentation, including IMPDs, IBs, and
• Communicate submission status, timelines, risks, and regulatory considerations effectively with
• Support business development activities by reviewing study budgets and costing, contributing to

🎯 Requirements

• Bachelor's degree or equivalent four-year college education with a major concentration in medical
• Alternatively, a two-year college qualification or equivalent education/training, such as a nursing
• Minimum 5–7 years of experience within the pharmaceutical or CRO industry, with demonstrated
• Proven leadership, organizational management, planning, strategic thinking, scheduling, monitoring
• Strong understanding of regulatory processes and clinical research requirements, with the ability
• Excellent written and verbal English communication skills, with the ability to present complex

🎁 Benefits

• Opportunity to work in an international clinical research and regulatory affairs environment
• Exposure to regulatory activities across EMEA, Asia Pacific, and Latin America
• Opportunities for professional development, coaching, and leadership growth
• Collaborative and supportive working environment focused on innovation and high-quality clinical
• Opportunity to contribute to programs supporting the development of innovative medical products
• Inclusive workplace culture that values diverse backgrounds, perspectives, collaboration, and