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Global Regulatory and Operations Director
2 months ago
EPM Scientific seeks a seasoned professional to lead our Regulatory Affairs Operations team. As Senior Director Global Regulatory and Operations, you will be responsible for overseeing the strategic direction of our RA operations, including global regulatory, regulatory systems, global vendors, processes, and data analytics.
Key Responsibilities
- Ensure continued compliance of our RA operations across multiple countries in the EU and Canada.
- Deliver RA services across multiple countries, utilizing either internal or vendor resources.
- Develop and manage the RA budget, ensuring timely and within-budget delivery of services.
- Lead the development of our RA systems strategy, providing a clear vision to senior management for endorsement and approval.
- Evaluate new technologies for future enhancements and improvements, and lead implementation plans.
- Stay up-to-date on regulatory guidance and communicate impact and strategy to senior leaders.
- Oversee the implementation of regulatory guideline changes.
- Ensure all RA systems are sourced, implemented, maintained, and fit for purpose.
Your Profile
- Bachelor's degree in life sciences.
- Extensive experience as a regulatory professional, with a focus on leading RA operations in the EU or Canada.
- Proven track record of vendor oversight and outsourcing delivery models.
- Strong leadership and problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to engage effectively with senior leaders.
- Effective collaborator with a strong customer and stakeholder focus.
- Excellent knowledge of regulatory systems, regulatory systems direction, and systems guidelines.
