Global Regulatory Submissions Specialist

MENARINI Group; Firenze; In loco; EUR 42.000 - 64.000; Tempo pieno

Descrizione del lavoro

MENARINI Group in Florence, Italy, seeks an experienced Regulatory Publishing Specialist for maternity cover within Global Regulatory Affairs Operations. You will prepare, assemble and deliver accurate electronic regulatory submissions, collaborating with Global, Regional and Local stakeholders.

The role requires a Master’s degree and 3+ years in Regulatory Affairs/Operations, with proficiency in docuBridge and Veeva RIM, and fluent English.

Competenze

• Master’s degree or higher in scientific discipline, information technology, or a related field.
• 3+ years’ experience in Regulatory Affairs and/or Operations or related discipline, preferably in pharma.
• Aptitude for IT environment (basic and specific software).
• Experience in document publishing and sequence publishing activities.
• Proficient with docuBridge and basic knowledge of Veeva RIM suite.
• Good spoken and written English.
• Dynamic, proactive and willing-to-do person.
• Excellent analytical, problem solving and communication skills.
• Excellent planning and organizational skills.
• Excellent team player with ability to work across organizational levels.

Mansioni

• Plan and organize activities for regulatory submissions in electronic format with stakeholders (Global, Regional, Local).
• Ensure documents meet quality standards and eSubmission requirements; advise on document authoring for electronic submission.
• Develop and implement templates to streamline document preparation for submissions.
• Support other departments in producing documents compliant with submission requirements.
• Participate in projects to select and implement regulatory software and harmonize processes.
• Actively participate in project teams.
• Monitor global submission requirements and assess impact on Menarini projects.

Conoscenze

Regulatory Affairs

Operations

IT aptitude

Document publishing

docuBridge

Veeva RIM

English proficiency

Team player

Planning

Problem solving

Formazione

Master’s degree or higher

Strumenti

docuBridge

Veeva RIM

Descrizione del lavoro

MENARINI Group in Florence, Italy, seeks an experienced Regulatory Publishing Specialist for maternity cover within Global Regulatory Affairs Operations. You will prepare, assemble and deliver accurate electronic regulatory submissions, collaborating with Global, Regional and Local stakeholders.

The role requires a Master’s degree and 3+ years in Regulatory Affairs/Operations, with proficiency in docuBridge and Veeva RIM, and fluent English.