Description

In this leadership role, you will guide regulatory strategies across Europe and international markets, ensuring compliance and market access for products while collaborating with key stakeholders and regulatory bodies.

Requirements

• •Thorough understanding of drug development process and pharmaceutical industry
• •Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs
• •Strong business acumen
• •Very strong strategic skills
• •Proven ability to deliver on goals in a cross-functional team
• •Willingness to explore new technologies and processes
• •Strong leadership of people
• •Excellent verbal and written skills
• •Skilled in conflict resolution and negotiation
• •Strong negotiating skills and creativity
• •Proven ability to build trust and respect
• •Proficiency in Microsoft Office applications and Veeva Vault
• •Flexibility to work when needed

Tasks

• •Build and lead regulatory groups
• •Develop and implement regulatory strategies
• •Ensure compliance with regulatory requirements and standards
• •Provide strategic regulatory oversight for projects
• •Represent regulatory affairs on leadership teams
• •Interface with EMA and national regulators
• •Provide insights on evolving regulatory policies
• •Manage line management and performance development
• •Establish and manage high-performance regulatory teams
• •Build partnerships with key stakeholders
• •Maintain trusting relationships with regulators
• •Create a supportive environment for the regulatory team
• •Provide strategic direction and mentorship on projects
• •Apply knowledge of drug development and regulatory requirements
• •Maintain up-to-date regulatory knowledge and understanding
• •Ensure high quality of CTAs and MAAs
• •Support establishment of new affiliates
• •Develop and execute local regulatory strategies
• •Leverage new technologies for efficient submissions

Tools & Technologies