Regulatory Affairs PM - Hybrid, Global Submissions

Perrigouk; Rotterdam; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Career development opportunities

Job summary

Perrigo in the Netherlands is seeking an experienced Regulatory Affairs Project Manager to drive submissions, approvals and product lifecycle management within a dynamic regulatory landscape. You will advise internal teams and external stakeholders, ensuring timely regulatory filings, labeling accuracy, and market access across Benelux while aligning with EU requirements.

A Master’s degree in Life Sciences or related field with 4+ years in Regulatory Affairs is required; fluent Dutch and English

Qualifications

• Master’s degree in Life Sciences, Foods, Pharmacy, or related field.
• At least 4 years of experience in Regulatory Affairs.
• Knowledge of local and EU regulations; Benelux regulatory frameworks.
• Strong communication and project management skills.
• Ability to work autonomously in local and international teams.
• Fluent in Dutch and English; French/German is a plus.

Responsibilities

• Assist in execution of regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals.
• Highly involved in the products’ lifecycle, including New Product Development (NPD) and launches, lifecycle maintenance and promotional activities.
• Support manufacturing and procurement in the management of change to existing commercial products.
• Maintain product labeling in compliance with local and EU laws and regulations; develop and approve label specifications in compliance with SOPs.
• Support the development and approval of packaging materials in a timely manner.
• Process change requests in compliance with GMPs and regulations.
• Maintain regulatory files and data systems in compliance with SOPs.
• Ensure timely and effective communication and collaboration with other departments including marketing, CS&I (trade marketing), sales and corporate regulatory and innovation.
• Review technical documentation and manage regulatory submissions in a timely manner.
• Process feedback from regulatory authorities and notified bodies.
• Support the development and clearance of promotional materials.
• Provide input for analysis of data and/or management review, if required.
• Assist in the process of reporting and investigating critical non-conformities and opportunities for improvement.

Skills

Regulatory affairs

Project management

Communication

Autonomy

Regulatory frameworks

Education

Master’s degree in Life Sciences, Foods, Pharmacy, or related field

Job description

Perrigo in the Netherlands is seeking an experienced Regulatory Affairs Project Manager to drive submissions, approvals and product lifecycle management within a dynamic regulatory landscape. You will advise internal teams and external stakeholders, ensuring timely regulatory filings, labeling accuracy, and market access across Benelux while aligning with EU requirements.

A Master’s degree in Life Sciences or related field with 4+ years in Regulatory Affairs is required; fluent Dutch and English