Regulatory Consultant (EU Centralized Regulatory Procedure experience)

Syneos Health is seeking a Regulatory Consultant with experience in EU Centralized Regulatory Procedure. The successful candidate will have a minimum of 4-5 years of experience in Regulatory Affairs, an M.Pharm degree, and experience serving as a Regulatory Lead for a portfolio of products.

Responsibilities:

• Conduct research of existing product data relative to global or regional regulatory requirements
• Contribute to or prepare administrative and technical components of regulatory agency submissions
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects
• Participate as regulatory support on multidisciplinary project teams
• Act as a subject matter expert and help team members with day-to-day troubleshooting activities
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals
• Support meetings with clients to discuss proposals and project status
• Ensure compliance with global regulatory requirements and company policies
• Prepare training materials and share best practices in the regulatory area
• Participate in internal or external project audits
• Contribute to the creation and/or maintenance of SOPs and other process-related documentation

Qualification Requirements:

• Demonstrated experience in contributing to the preparation of regulatory submissions
• Excellent interpersonal and communication skills
• Excellent customer service skills
• Good quality management skills
• Advanced skills in Microsoft Office Applications
• Ability to interact with staff from multiple departments and offices
• Good initiative, adaptability, and pro-activity
• Strong analytical skills and attention to detail
• Ability to work concurrently on projects
• Fluent in speaking, writing, and reading English