Regulatory Affairs Specialist - EU&North America

Manpower; Firenze; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading recruitment agency is seeking a Regulatory Affairs Specialist in Florence, Tuscany. This role involves managing product registrations and lifecycle maintenance while collaborating with various internal and external teams. Candidates should have a Bachelor's in a scientific field, at least three years of experience in regulatory affairs, and fluent English skills. The position requires a proactive mindset and strong communication skills. Join a dynamic team contributing to pharmaceutical product management.

Competenze

• At least 3 years of previous experience in an international regulatory affairs department for pharma products.
• Dynamic, proactive, and willing-to-do profile.

Mansioni

• Planning activities for preparing new product registrations and maintenance.
• Collaborating with internal functions and external partners on regulatory applications.
• Preparing the master data package for submission to authorities.
• Monitoring new RA regulations and guidelines.

Conoscenze

Fluent in English

Excellent interpersonal skills

Organizational skills

Problem-solving attitude

Formazione

Bachelor Degree in scientific environment

Descrizione del lavoro

Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a

REGULATORY AFFAIRS SPECIALIST

Within the Global Regulatory Affairs department - EU and North America area (EUNA), we are looking for a Regulatory Affairs Specialist with a direct report to the EUNA Therapeutic Area Manager. The resource will be responsible of handling a specific portfolio of products, guaranteeing the obtainment of new registrations and/or the maintenance of the existing ones in the Region in scope.

MAIN ACTIVITIES AND RESPONSIBILITIES

Within the EUNA Regulatory Affairs team and under the guidance of the Therapeutic Area Manager, the resource will deal with the registrations and/or life cycle maintenance activities of the products in the specialty and primary care area. It will include, at least:

• Planning/organizing activities for preparing new product registration and/or maintenance of the existing registration through variation procedures and renewals
• Working in cooperation with technical internal functions (such as Quality Assurance, Medical, Marketing, Clinical, Pharmacovigilance), and local regulatory teams or external partners for the preparation of the regulatory application related to new registrations and/or lifecycle management
• Preparation of the master data package to be shared with the local regulatory affairs contacts in order to proceed with the customization, as necessary, and submission of the application to the competent Authority/ies
• Preparation and management of the paediatric application and relevant update, if any
• Application of the existing working flows and Company procedures
• Monitoring and understanding of new RA regulations and guidelines for the area of responsibility.

JOB REQUIREMENTS

• Bachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatory
• At least 3 years of previous experience in an international regulatory affairs department for pharma products
• Fluent in English, both written and oral
• dynamic, proactive and willing-to-do profile
• Excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude.

Regulatory Affairs Specialist • Firenze, Toscana