Line Manager / Regulatory Affairs Manager Italy

Resourcing Life Science; Italia; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading life sciences company in Italy is seeking a Regulatory Affairs Manager to oversee regulatory submissions and engage with authorities to support product registrations. The ideal candidate must possess at least 8 years of regulatory affairs experience, including 4 years in a managerial role. Strong knowledge of EMEA and FDA requirements is essential. The position requires excellent communication skills in English and availability for 4 days in the office.

Competenze

• Minimum 8 years of experience in regulatory affairs.
• At least 4 years as a Regulatory Affairs Manager.
• Strong knowledge of EMEA/FDA requirements.

Mansioni

• Manage line training for Regulatory Specialist.
• Establish regulatory submission timelines.
• Engage with regulatory authorities for product registrations.
• Conduct global regulatory impact assessments.

Conoscenze

Regulatory Affairs expertise

Line management

Efficacy of regulatory submissions

Regulatory impact assessments

Collaboration across teams

Fluent English

Descrizione del lavoro

What to Expect

• Line management, training of Regulatory Specialist
• Training of the direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Engage with regulatory authorities and distribution partners to support product registrations
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
• Support and participate in inspections and audits conducted by global regulatory authorities.

Requirements

• Min 8 years in regulatory affairs
• Min 4 years as Regulatory Affairs Manager
• Experience with EMEA / FDA regulatory requirements
• Ideally line management of a team
• Excellent written and verbal in English
• Availability to work 4 days in the office

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]