Local Regulatory Responsible

22 ago - Milano
csl

Local Regulatory Responsible (LRR) (m/f/x) - ItalyLocation: 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 pre

Real World Evidence Lead Endo-Metabolic, Global Rare Diseases

24 ago - Parma
Chiesi Farmaceutici

Addetto/A Qualita' - Sicurezza - Ambiente - Fino A €50.000 All'Anno

24 ago - Caldogno
Bicego HR

Ricevi nuove offerte di lavoro

Crea una Job Alert gratuita per local regulatory responsible / milano

CONSULENTE DEL LAVORO LIBERO PROFESSIONISTA

24 ago - Caselle torinese
Iqm Selezione S. R. L

Senior EnergyB Account Leader - Portafoglio in crescita

24 ago - Ancona
HRSpecialist Italia - Il Tuo Nuovo Lavoro