09 set - Pavia
csl
Local Regulatory Responsible (LRR) (m/f/x) - Italy
Location: Milan, Italy
Contract Type: Permanent contract, Fulltime
Department: Regulatory Affairs
The Opportunity
In this role, you will serve as the primary regulatory representative for Italy, ensuring compliance with local regulations, leading interactions with Health Authorities, and supporting product registrations and lifecycle management activities. You will work closely with regional regulatory teams, commercial operations, and external stakeholders to drive regulatory excellence and business success.
The Role
- Provide local regulatory expertise and input to support the development and execution of regulatory strategies for new product registrations and lifecycle management activities.
- Review promotional materials and provide regulatory guidance to ensure compliance with local regulations.
- Monitor and communicate progress of regulatory projects to relevant stakeholders.
- Ensure compliance with Italian regulatory requirements and evolving legislation.
- Support audit and inspection readiness activities and ensure timely implementation of corrective and preventive actions (CAPAs).
- Monitor changes in the regulatory landscape and communicate emerging requirements and industry trends to internal stakeholders.
- Participate in regulatory meetings, industry forums, and trade associations to represent company interests and share insights.
- Maintain compliance-related KPIs and ensure regulatory information systems (RIMS) remain accurate and up to date.
- Serve as the primary contact for Italian Health Authorities and regulatory stakeholders.
- Build and maintain strong relationships with Health Authorities, industry groups, and trade associations.
- Lead local regulatory interactions related to licenses, submissions, and market access initiatives.
- Act as the regulatory representative for local Commercial Operations, providing strategic guidance and business-focused regulatory support.
- Coordinate and pr
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