Global Regulatory Strategy Lead(m/w/x)

Beschreibung

You will lead global regulatory strategies for transformative CRM therapies, driving health authority interactions and collaborating across teams to bring innovative treatments to patients.

Anforderungen

• •Advanced degree in pharmacy or life sciences
• •Specialized Pharmacist or Regulatory Affairs Master's
• •Long term pharmaceutical or biotechnology experience
• •Deep understanding of Global Regulatory Affairs
• •Therapeutic area expertise in CRM
• •Track record in global regulatory strategies
• •Experience with (s)BLA, (s)NDA, or MAA
• •Negotiation experience with FDA or EMA
• •Knowledge of global guidelines and SOPs
• •Ability to analyze complex scientific data
• •Calm and focused approach under pressure
• •Excellent interpersonal and leadership skills
• •High business acumen and strategic thinking
• •Persuasive written and verbal communication
• •Strong decision-making and problem-solving capabilities

Aufgaben

• •Act as the primary regulatory interface for cross-functional teams
• •Lead the Regulatory Excellence Team for assigned projects
• •Develop and execute innovative global regulatory strategies
• •Author the Global Regulatory Strategy document
• •Contribute to Target Product Profiles and target labels
• •Drive regulatory interactions with health authorities in strategic markets
• •Collaborate with regional and local regulatory colleagues
• •Provide strategic input on clinical trial protocols and study reports
• •Review CTAs, INDs, and pediatric development plans
• •Review core dossier components for regulatory submissions
• •Ensure compliance with global regulatory standards
• •Implement departmental policies and best practices
• •Monitor scientific and regulatory developments in the CRM area
• •Integrate pharmacovigilance and market access insights into strategies

Tools & Technologien