Senior Regulatory Affairs Consultant Lazio

Senior Regulatory Affairs Consultant
Roma
Lazio, Lazio

Senior Regulatory Consultant Location: Rome- Hybrid Contract Duration: 1 year Initially Company: Global Pharmaceutical Company Job Summary Provide local regulatory and technical support for assigned products, including regulatory submissions, product development documentation, and the management of project-related regulatory activities.

Key Responsibilities For both simple and complex submissions, independently handle the following tasks: Monitor and stay updated on local regulatory requirements, anticipating and communicating changes to relevant stakeholders.

Support responses to inquiries from other departments (e. g. , medical, supply chain) regarding compassionate use, early access programs, labeling exemptions, clinical trial application (CTA) requirements, etc.

Ensure compliance with national requirements related to marketing authorization applications (MAAs) and subsequent variations for centrally approved products.

Review and approve translations for artworks and product information.

Assess promotional and non-promotional materials for compliance with local regulations, submitting or obtaining approvals where necessary.

Act as a regulatory expert in multidisciplinary teams, collaborating with clinical and technical professionals throughout product development.

Provide guidance and troubleshooting support on regulatory matters, offering practical solutions to project-related challenges.

Ensure adherence to local regulatory standards, policies, and company procedures.

Qualifications & Skills BS or PhD in a science-related field or equivalent experience in regulatory affairs, medical writing, or a related domain.

At least 6 years of experience in the pharmaceutical or biotech industry within regulatory affairs.

Proven expertise in preparing Italian regulatory submissions, including variations, responses to agency queries, and MAAs.

Experience managing negotiations with AIFA.

Strong communication and interpersonal skills, with excellent written and verbal proficiency.

Native Italian speaker with fluency in English (spoken, written, and reading).

Strong problem-solving abilities and experience working in cross-functional teams.

Proficiency in Microsoft Office applications.

Attention to detail, analytical mindset, and proactive approach to tasks.

Good understanding of quality management processes.