Regulatory Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7925w0

The Regulatory Affairs Specialist provide regulatory and operational support across a broad range of activities, ensuring that medicinal products and medical devices, where applicable, remain compliant with Italian and European regulatory requirements throughout their lifecycle.

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Reporting to the Regulatory Affairs, Quality Assurance & Pharmacovigilance Associate Director, will work closely with internal departments and external stakeholders and will contribute to the maintenance of product compliance, support regulatory submissions, and ensure adherence to applicable regulatory and local pharmacovigilance requirements.

Key ResponsibilitiesRegulatory Affairs Responsibilities

- Support the local implementation and maintenance of centrally authorized products, ensuring compliance with Italian regulatory requirements and effective coordination with Global Regulatory Affairs for all EMA-managed procedures.
- Manage local product lifecycle activities, including the implementation of variations, renewals, notifications, and other post-approval changes, in close collaboration with Global Regulatory Affairs and relevant stakeholders.
- Support the local review and approval of translated product information texts, packaging artworks, ensuring timely and compliant implementation.




- Collaborate in review and approval of promotional and non-promotional materials to ensure compliance with applicable regulations and company procedures, in collaboration with RSS.
- Maintain accurate regulatory documentation and ensure timely updates to internal systems and databases, in accordance with company requirements.
- Provide support to internal stakeholders (commercial, medical, access) on local regulatory requirements and procedures, to support business objectives while maintaining regulatory compliance.
- Support Regulatory Intelligence activities by monitoring changes in applicable regulations, guidelines and industry practices.
- Support the implementation, maintenance and distribution of Risk Management Plan (RMP) educational materials in collaboration with Medical Affairs.
- Contribute to the development, maintenance and periodic review of local Standard Operating Procedures (SOPs), Working Instructions and Regulatory Affairs processes.

Pharmacovigilance Support
- Support implementation and maintenance of local Pharmacovigilance processes in accordance with global procedures, local regulations and Good Pharmacovigilance Practices (GVP).
- Assist in managing Pharmacovigilance-related agreements with External Service Providers (ESPs). xlwpduy
- Support inspections, audits and compliance checks related to Pharmacovigilance activities.

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7925w0