Manager, Regulatory Affairs – EMEA

• Review study budgets and costing related to contract negotiation
• Participate in business development activities
• Prepare regulatory sections of proposals and feasibility reports
• Attend bid defense meetings
• Coordinate and manage regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America
• Maintain approvals and ensure accurate compilation, management, and tracking of submissions
• Provide expert regulatory advice and contribute to regulatory project work
• Communicate submission status with Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs staff
• Contribute to technical documentation such as IMPDs and IBs
• Review documentation and make recommendations to ensure compliance with ICH GCP and country-specific requirements
• Provide training, coaching, and mentoring to junior staff
• May line manage junior staff

• Clearly proven leadership and organizational management skills
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills
• Relationship-building competency and comfort supporting Business Development at face-to-face meetings
• Strong interpersonal skills in a fast-paced, deadline-oriented, changing environment
• Ability to handle multiple tasks in a fast-paced and constantly changing environment
• Minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science; OR two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research
• Minimum 5–7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
• Proficiency in cross-cultural communication
• Proficiency in spoken and written English

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
• Supportive and cohesive teams
• Diverse and inclusive workplace
• Opportunities for training, coaching, mentoring, and professional development