Senior Manager Regulatory Affairs

Primary Responsibilities:

• Regular contact with the relevant affiliates to forecast country-specific issues, the effects of SPC on promotion, in pricing and reimbursement, and more.
• Give direction to the team on regulatory outcomes and processes.
• May have responsibility Steering responsibilities for managing, training and development of associates.

Program/Product Team:

• Manage the input into the Core Label. Ensure the needs for local patients in Clinical Trials are met for countries in the IBU.
• Provide detailed expertise on European procedures for registrations and interpretation of guidelines and anticipate impact of changes.
• Hands on with regulatory strategies for NCEs, new indications and line extensions

Business:

• Participate in IBU meetings to ensure regulatory strategy and issues are considered and learn about business needs.
• Link technical expertise with business knowledge to influence and impact cross-functional initiatives and drive optimum solutions.
• Provide awareness of the current registration environment and work to influence to our advantage when possible.

Requirements:

Technical Knowledge:

• Bachelor’s, master’s degree or PhD in a relevant Life Science Subject 
• Solid understanding of European regulations and procedures in IBU countries
• Knowledgeable and good understanding of multiple therapeutic areas
• Able to apply knowledge across several stages of drug development
• Solid experience in regulated environment or/and good experience in a research-based drug development