Senior Director, Regulatory Affairs, Italy
$144,000–$179,000 year
Remote
Job Summary
Lead the Regulatory Affairs organization at the country level, providing vision and direction for assigned projects and territories in accordance with ICH, Italian, and EU regulations. Manage affiliate inspections, audits, quality defects, and batch recalls while ensuring compliance with marketing authorization holder responsibilities. Coordinate national scientific consultations, pre-submission meetings, and risk mitigation materials; oversee promotional material approvals and product packaging updates. Monitor Italian regulatory guidelines, communicate updates to global teams, and contribute to new regulatory guidelines. Lead creation and continuous improvement of procedures, SOPs, and training programs. Plan, monitor, and optimize resources and budget for portfolio development. Manage distribution and wholesale licenses and serve as the information officer. Travel up to 30% of the time.
Required Qualifications
- Master's / PhD degree in scientific or medical discipline
- 10+ years of experience in regulatory leadership roles or in a similar role within the pharmaceutical or biotech industry
- Strong understanding of the regulatory framework in Italy and the EU
- Knowledge and experience within the oncology therapeutic area
- Excellent verbal and written communication skills in Italian and English
- Proven ability to analyze and summarize scientific information effectively
- Excellent presentation skills, with the ability to effectively communicate complex scientific data to diverse audiences
- Strong networking skills with proven ability to successfully build and maintain relationships with Italian regulatory bodies and healthcare professionals
- Independent and able to thrive in a fast-paced and dynamic environment
- Willingness to travel up to 30% of time
Desired Qualifications
- Preferred experience in oncology
- Experience with both early and late-stage clinical assets as well as approved therapies
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