Manager, Regulatory Affairs

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85b6u2

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Regulatory Affairs based in Italy.
This role offers the opportunity to lead regulatory affairs activities across multiple international markets within a dynamic clinical research environment. You will oversee regulatory and ethics committee submissions, ensuring accurate, timely, and compliant execution throughout the study lifecycle. The position combines strategic regulatory guidance with hands‑on project coordination and stakeholder management. You will work closely with sponsors, project teams, medical and scientific experts, and business development colleagues. The role also provides opportunities to contribute to proposals, feasibility assessments, contract discussions, and technical documentation. As a senior member of the team, you will share your expertise through coaching and mentoring junior colleagues. Your work will directly support the development and regulatory advancement of innovative medical products and clinical research programs.




Accountabilities
- Lead and coordinate regulatory and ethics committee submissions and maintain required approvals across EMEA, Asia Pacific, and Latin America.
- Ensure regulatory submissions are accurately compiled, managed, tracked, and maintained in accordance with applicable requirements and timelines.
- Provide expert regulatory guidance throughout clinical research projects and advise stakeholders on country-specific and international regulatory requirements.
- Review and provide recommendations on technical and study documentation, including IMPDs, IBs, and other relevant materials, to ensure alignment with ICH GCP and applicable country requirements.
- Communicate submission status, timelines, risks, and regulatory considerations effectively with sponsors, Project Managers, CRAs, and Medical & Scientific Affairs teams.
- Support business development activities by reviewing st

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/85b6u2