Regulatory Affairs Project Manager

Description Overview

We are currently seeking a Regulatory Affairs Project Manager to join our highly successful Central Regulatory Affairs medicines team.

This role is responsible for managing new Marketing Authorisation and life cycle maintenance projects for medicinal product portfolios across the EU, ensuring compliance with legislative frameworks and internal policies. Our medicines team operates from multiple locations in the EU, with main hubs in London, Paris, Ghent, and Rotterdam.
 
As a Regulatory Affairs Project Manager, you will lead regulatory projects from strategy to approvals, working with central and local Regulatory teams to ensure our products comply with relevant legislation, including the EU Medicines Directive and Variation Regulation as well as other national legislation.

You will maintain regulatory compliance, stay updated on regulatory requirements, and implement necessary changes.

Additionally, you will support various regulatory and cross functional areas, helping to create and maintain robust ways of working and collaboration. 
A strong background in EU regulatory affairs for medicinal products, with excellent communication skills, attention to detail and demonstrated ability to manage multiple ongoing projects are essential.

Scope of the Role

• Lead regulatory activities for assigned projects and brands; providing updates to stakeholders and reporting against project plans
• Support brand management, including product name strategy, core product information text, review of claims, global advertising material and pack design
• Develop regulatory strategies for product lifecycle maintenance and new MAA projects, identifying risks and opportunities.
• Manage, execute and coordinate product lifecycle maintenance projects (including variations, renewals and safety updates) and new MAA applications.
• Develop, roll out and maintain relevant internal procedures and best practices.
• Support the regulatory intelligence best practice and implementation of changes to legislation.
• Support CSCI RA engagement and enablement projects
• Maintain the integrity of regulatory data in the relevant databases.
• Carry out any other regulatory tasks as required

Experience Required

• Bachelor or Master’s degree in International Law, European Policies, Medical/Life Sciences or other relevant fields.
• Postgraduate qualification desirable
• 5 years of experience in a relevant regulatory environment
• Experience in drug development and manufacturing supply processes 
• Knowledge of specific regulatory requirements in Europe
• Self-motivated, flexible an open to changing requirements.
• Highly driven with enthusiasm to meet requirements and cope under demanding pressure.
• Excellent spoken and written communication skills; able to represent Perrigo during interactions and negotiations with external agencies.
• High accuracy and attention to detail.
• Project management skills and the ability to work autonomously with guidance when required.
• Ability to make decisions, problem solve, prioritise and multi-task.
• Ability to influence, negotiate and manage stakeholders.
• Focus on continuous improvement.
• Provide coaching, mentoring and knowledge within the Regulatory department.