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Regulatory Project Coordinator
3 months ago
Company: SoftPathTechnologies
Work Arrangement: Hybrid schedule with in-office and remote work options
Key Responsibilities:
- Formulating and overseeing regulatory strategies for various initiatives
- Acting as the primary contact for designated programs
- Offering regulatory guidance for product development
- Crafting and implementing regional regulatory approaches
- Representing the organization in discussions with regulatory bodies
- Leading submissions to US regulatory agencies
- Keeping abreast of regulatory standards and guidance
- Assisting in due diligence processes
- Encouraging ethical practices and exemplary conduct
- In-depth understanding of US pharmaceutical development and regulations
- Proven experience in delivering strategic regulatory counsel
- Capability to handle multifaceted projects
- Excellent communication and interpersonal abilities
- Demonstrated history of sound decision-making and risk evaluation
- Awareness of emerging regulations and guidelines
- Bachelor's Degree in a relevant field
