Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. They are recruiting a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials and regulatory agency meetings.

Requirements

• Bachelor's degree in a scientific or healthcare discipline
• 5 years Regulatory experience for the Manager level and 7 years for the Senior Manager Regulatory level
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Regulatory affairs experience working for a Clinical Research Organisation and experience leading Clinical Submissions
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US)
• Ability to understand clinical and pre-clinical study results
• Knowledge of clinical trials methodology and relevant regulations and guidance supporting pharmaceutical development

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance