Accountable for oversight and strategic direction of Regulatory Affairs (RA) Operations, including Global regulatory, Regulatory systems, Global vendors, processes and data analytics.
Accountable for Global RA delivery in certain countries (EU and Canada). Responsible for the strategy and procurement activities for company's Regulatory Affairs operational and systems vendors in line with a portfolio innovation and business requirements. Accountable for Regulatory vendor oversight, budget and their delivery.
Key Responsibilities
- Accountable for continued compliance of company's RA across multiple countries in EU and Canada
- Accountable for RA delivery across multiple countries, with either internal or vendor resource
- Accountable for delivering RA to meet the Business requirements within the budget
- Accountable for tracking and maintaining the RA budget
- Accountable for the RA Systems strategy, providing a clear vision to senior management for endorsement and approval and delivering against this vision on time and on budget.
- Evaluate new technologies for future enhancements and improvements and lead any plans for implementation.
- Evaluate changes in regulatory guidance and highlight impact and impact strategy management to senior leaders.
- Responsible for leading any corresponding regulatory guideline impact implementation.
- Accountable for all systems used within RA ensuring that they are sourced, implemented, maintained and fit for purpose.
Your Profile
- BSc degree in life sciences
- Extensive work as a regulatory professional essential.
- Experience of leading Regulatory Operations (RA experience in EU or Canada)
- Experience of vendor oversight and outsourcing delivery models
- Strong leadership and problem solving skills.
- Excellent communication skills and ability to engage with Senior Leaders within the organisation effectively.
- Effective collaborator and strong customer and stakeholder focus.
- Excellent knowledge of regulatory systems, regulatory systems direction and systems guidelines.