Regulatory Manager

📋 Description

• Provides regulatory development advice for clinical development life cycle
• Coordinates and reviews regulatory submissions to Authorities/Ethics Committees (CTA/IND, annual
• Maintains current regulatory knowledge and supports project teams and regulatory function
• Serves as Global Regulatory Affairs representative at project team meetings
• Oversees regulatory targets, plans, and intelligence tools; leads regional/global projects when
• Maintains project plans and trackers; updates Regulatory Leadership

🎯 Requirements

• Bachelors degree required; plus experience in scientific/healthcare field preferred
• 5+ years or more regulatory affairs experience
• Strong knowledge of EU/US regulatory activities, including INDs/CTAs, submissions, scientific
• Understanding of clinical and pre-clinical study results; ability to interpret data for regulatory
• Knowledge of ICH GCP guidelines; familiarity with regulatory milestones and milestones planning
• Fluent in English; excellent written and verbal communication; strong interpersonal skills

🎁 Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave