Manager, Global Regulatory Strategy

• Develop and implement US regulatory strategy for unique products
• Provide strategic regulatory input and execution support to assigned programs
• Coordinate regulatory submissions and manage local marketing authorization applications
• Monitor the development of new regulatory requirements and guidance documents
• Contribute to effective ways of working and consistent regulatory practices

• 5+ years of experience in pharmaceutical industry regulatory affairs
• Bachelor's Degree, preference to a scientific or a clinical degree
• Strong knowledge of drug development and regulatory policy
• Experience providing strategic regulatory advice for product development
• Ability to manage complex issues and coordinate multiple projects
• Ability to build intra-team relationships and collaborate in a global environment
• Strong interpersonal and written/verbal communication skills
• Understanding of GMPs, GLPs and GCPs

Demonstrates expertise in developing and implementing regulatory strategies for pharmaceutical products, with a strong focus on drug development, regulatory policy, and compliance with GMPs, GLPs, and GCPs. Proven ability to provide strategic regulatory advice and manage complex projects in a collaborative global environment.

• Regulatory Strategy Development
• Pharmaceutical Industry Regulatory Affairs
• Drug Development Knowledge
• GMPs, GLPs, and GCPs Understanding
• Strategic Regulatory Advice

• Regulatory Submissions Management
• Local Marketing Authorization Applications
• Regulatory Policy Knowledge
• Project Coordination
• Complex Issue Management

• Interpersonal Skills
• Written Communication
• Verbal Communication
• Collaboration
• Relationship Building

• Bachelor's Degree in Scientific or Clinical Field

• Regulatory Affairs
• Pharmaceutical Industry
• Regulatory Requirements
• Guidance Documents
• Effective Ways of Working