- 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
Requirements
- 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
Core Competencies
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.
Highest-signal resume keywords
- Regulatory Strategy Development
- Pharmaceutical Industry Regulatory Affairs
- Drug Development Knowledge
- GMPs, GLPs, and GCPs Understanding
- Strategic Regulatory Advice
ATS Optimization Keywords
Hard Skills
- Regulatory Submissions Management
- Local Marketing Authorization Applications
- Regulatory Policy Knowledge
- Project Coordination
- Complex Issue Management
Soft Skills
- Interpersonal Skills
- Written Communication
- Verbal Communication
- Collaboration
- Relationship Building
Certifications & Qualifications
- Bachelor's Degree in Scientific or Clinical Field
Industry Keywords
- Regulatory Affairs
- Pharmaceutical Industry
- Regulatory Requirements
- Guidance Documents
- Effective Ways of Working