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About the Role
This role involves leading and developing a team by managing performance, resources, and employee relations while ensuring alignment with organizational policies and regional/global strategy. The individual oversees workload, quality, and team effectiveness, collaborates cross-functionally to address operational challenges, and drives the implementation of strategic initiatives. They hold full financial accountability for one or more Regulatory Affairs sites, including performance monitoring and risk management, and may lead complex projects or provide strategic regulatory consultancy. Additionally, the role includes engaging with regulatory authorities, contributing to business development activities such as bid defense, and representing the organization through presentations and thought leadership in the field.
Responsibilities
- Manage performance, resources, and employee relations.
- Ensure alignment with organizational policies and regional/global strategy.
- Oversee workload, quality, and team effectiveness.
- Collaborate cross-functionally to address operational challenges.
- Drive the implementation of strategic initiatives.
- Hold full financial accountability for one or more Regulatory Affairs sites.
- Monitor performance and manage risks for Regulatory Affairs sites.
- Lead complex projects or provide strategic regulatory consultancy.
- Engage with regulatory authorities.
- Contribute to business development activities, including bid defense.
- Represent the organization through presentations and thought leadership.
Requirements
- 8+ years of regulatory affairs experience in pharma or a CRO.
- 6+ years of management experience in regulatory affairs.
- Proven success in leading and developing senior teams.
- Strong leadership, influencing, and negotiation skills.
- Ability to navigate complex stakeholder environments.
- Effective communication and ability to drive regulatory strategy.
- Resilience under pressure.
Skills
- Leadership
- Influencing
- Negotiation
- Stakeholder Management
- Communication
- Regulatory Strategy
- Team Development
- Financial Accountability
- Risk Management
- Project Management
- Regulatory Consultancy
- Regulatory Authority Engagement
- Business Development
- Thought Leadership
Experience Level
- 8+ years of regulatory affairs experience
- 6+ years of management experience