Regulatory Affairs Project Manager

Perrigo Company plc; Gent; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Perrigo Company plc in Belgium (Gent) is seeking an experienced Regulatory Affairs Project Manager to lead submission, approval and launch processes for new and existing products, ensuring timely market access.

You will advise internal teams and external stakeholders, manage lifecycle activities from development through labeling, packaging changes and promotional materials, while navigating local and EU regulations.

Qualifications

• Master's degree in Life Sciences, Foods, Pharmacy or a related field.
• At least 4 years of regulatory affairs experience.
• Strong knowledge of local and EU regulations and cross-border processes.
• Excellent communication and project management skills.

Responsabilités

• Lead regulatory activities to ensure submission, approval and launch of new products.
• Advise internal teams and external stakeholders on regulatory strategies.
• Manage lifecycle maintenance including labeling, packaging and promotional materials.
• Coordinate with manufacturing, procurement and other departments for Change Control.
• Maintain regulatory files and data systems in line with SOPs.
• Collaborate across teams in Benelux and EU markets to support market access.

Connaissances

Regulatory knowledge

Project management

Communication

Dutch language

English fluent

Formation

Master's degree in Life Sciences/Pharmacy

Description du poste

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

Are you an experienced Regulatory Affairs Project Manager with business acumen and a keen eye for detail?

We are looking for a new colleague to reinforce the regulatory activity required to submit, approve and launch new products and the maintenance of existing commercialized products and dossiers. In this role, you will be a key advisor to internal teams and external stakeholders, contributing to successful product registrations and market access projects, promotional campaigns, and protection of existing products in a fast changing regulatory environment.

Scope of the Role

• 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.

Experience Required

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

• At least 4 years of experience in Regulatory Affairs
• In-depth knowledge of local and EU regulations; at least in one of the countries of the Benelux and one or more of the following regulatory frameworks: medicines, medical devices, food supplements, biocides, general health products or cosmetic products.
• Strong communication and project management skills
• The ability to work both independently in local and international teams
• Strong communication, persuasion and problem-solving skills, with the ability to translate regulatory complexity to non-regulatory employees
• Curiosity - An eager and quick learner willing to develop and improve
• Fluent in Dutch and English is a must; knowledge of French and German is an asset

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

Hybrid Working Approach

We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo