Line Manager / Regulatory Affairs Manager Netherlands

Resourcing Life Science; Netherlands; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading life sciences recruitment agency is seeking an experienced Regulatory Affairs Manager in the Netherlands. You will manage regulatory submissions and ensure compliance with EMEA and FDA requirements. The ideal candidate will have over 8 years of regulatory affairs experience, with at least 4 years in a managerial role. Strong leadership and communication skills in English are essential, as is the ability to work 4 days in the office.

Qualifications

• 8+ years of experience in regulatory affairs, with a minimum of 4 years as a manager.
• Experience with EMEA and FDA regulatory requirements is crucial.
• Fluency in English, both written and verbal.

Responsibilities

• Manage regulatory submissions and timelines for global markets.
• Train and oversee the regulatory specialist and direct reports.
• Engage with regulatory authorities for product registrations.

Skills

Regulatory affairs expertise

Leadership

Strong communication skills

Job description

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]