Senior Manager, Regulatory Affairs - Europe - remote

What The Regulatory Affairs Department Does

At The Worldwide Regulatory Affairs plays a pivotal role in navigating the complex regulatory landscape, ensuring the success of diverse clinical trials. As subject matter experts, the team leads submissions to regulatory authorities, coordinates with ethics committees across EMEA, Asia Pacific, and Latin America, and ensures compliance with evolving regulations. Their expertise drives the development and approval of innovative medical products, supports business development efforts, and offers strategic guidance on contract negotiations. They also mentor junior staff, review key documentation for global regulatory standards, and keep all stakeholders informed throughout the submission process

What You Will Do

• Review study budgets and costing about contract negotiation
• Participate in business development activities
• Prepare regulatory sections of proposals and feasibility reports
• Attend bid defense meetings to meet business needs
• Career coordination & management of regulatory & ethics committee submissions
• Maintain approvals throughout EMEA, Asia Pacific and Latin America regions
• Ensure accurate compilation, management and tracking of submissions
• Provide expert regulatory advice and contribute to regulatory project work
• Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff
• Contribute towards the preparation of technical documentation such as IMPDs and IBs
• Review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements

What You Will Bring To The Role

• Clearly, proven leadership and organizational management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Excellent written and verbal communication skills to clearly and concisely present information
• Relationship-building competency combined with demonstrated comfort supporting Business Development at a face-to-face meeting
• Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
• Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment

Your Experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
• A two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years of experience within clinical research (e.g., CRA, Reg Affairs)
• Minimum 5-7 years within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience
• Proficient in cross-cultural communication and proficient in both spoken and written English