Global Regulatory Submissions Specialist

MENARINI Group; Toscana; On-site; EUR 42,000 - 64,000; Full time

Job summary

MENARINI Group is seeking a professional to join its Global Regulatory Affairs Operations team on maternity leave coverage. The role focuses on preparing, assembling and delivering accurate regulatory submissions in electronic format, coordinating with Global, Regional and Local stakeholders to ensure compliant, submission-ready packages.

The ideal candidate will have a Master’s degree or higher in a scientific field and 3+ years in regulatory affairs or related operations, with strong IT

Qualifications

• Master's degree or higher in scientific discipline, information technology, or related field.
• 3+ years’ experience in Regulatory Affairs and/or Operations or related discipline, preferably in pharma.

Responsibilities

• Plan and organize activities for preparation of regulatory submissions in electronic format with stakeholders.
• Check compliance with quality standards and electronic submission requirements; advise on document authoring for eSubmissions.
• Develop and implement templates to streamline document preparation for submissions.

Skills

Regulatory submissions

Project coordination

Documentation publishing

Veeva RIM basics

docuBridge

English proficiency

Team collaboration

Education

Master's degree or higher

Tools

docuBridge

Veeva RIM

Job description

MENARINI Group is seeking a professional to join its Global Regulatory Affairs Operations team on maternity leave coverage. The role focuses on preparing, assembling and delivering accurate regulatory submissions in electronic format, coordinating with Global, Regional and Local stakeholders to ensure compliant, submission-ready packages.

The ideal candidate will have a Master’s degree or higher in a scientific field and 3+ years in regulatory affairs or related operations, with strong IT