Senior Director, Regulatory Affairs, Italy
Revolution Medicines · Milan, Italy
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Role summary
Revolution Medicines seeks a Senior Director of Regulatory Affairs for its Italy operations. This strategic leadership role involves directing regulatory activities for oncology products across early-stage and marketed portfolios, managing Italian and EU compliance, and coordinating with global regulatory teams.
What they're looking for
- Extensive regulatory affairs experience in pharmaceutical industry
- Deep knowledge of Italian and EU regulatory requirements and ICH guidelines
- Proven leadership experience managing regulatory functions and teams
- Strong cross-functional collaboration skills with clinical, medical, and commercial teams
- Experience with pre-submission meetings and scientific consultations
- Familiarity with pharmacovigilance, product labeling, and promotional material review
What you'll be doing
- Lead regulatory strategy and provide strategic input on assigned projects and territories
- Coordinate national scientific consultations and pre-submission meetings with global teams
- Monitor Italian regulatory guidelines and communicate updates to regional and global organizations
- Review and approve promotional materials and ensure packaging compliance with regulations
- Develop and maintain regulatory procedures, SOPs, and policies for local requirements
Privacy & handoff
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