Global Regulatory Lead - Remote

Overview

As a Global Regulatory Lead, you will contribute to the development of pharmaceutical diagnostics from pre-clinical through clinical studies to initial registration in key global markets. You will be responsible for leading Global Regulatory Strategy Leadership and policy development.

In Short

• Lead global program development regulatory strategy.
• Coordinate with National Regulatory Affairs for submission readiness.
• Identify regulatory opportunities and potential risks.
• Guide and motivate internal and external stakeholders.
• Ensure fulfillment of regulatory compliance obligations.
• Proven track record in European and US licensing submissions.
• Knowledge of regulatory frameworks and external environments.
• Drive new regulatory approaches to expedite submissions.
• Ability to clearly convey information to stakeholders.
• Foster a culture of integrity and collaboration.

Requirements

• Experience in leading successful regulatory submissions.
• Strong interaction skills with health authorities.
• Knowledge of preclinical, CMC, and clinical regulations.
• Ability to influence and guide project teams.
• Experience in developing regulatory strategy documents.
• Strong communication and stakeholder management skills.
• Ability to drive new regulatory approaches.
• Demonstrated integrity and focus.
• Ability to work in a global team environment.
• Commitment to diversity and inclusion.

Benefits

• Competitive salary and benefits package.
• Relocation assistance provided.
• Opportunities for career development.
• Supportive and collaborative work culture.
• Flexible work environment.
• Commitment to diversity and inclusion.
• Access to innovative medical technology.
• Focus on employee well-being.
• Engagement in meaningful work.
• Global strength and scale of the organization.