Senior Regulatory Affairs Associate

Description Overview

In this role you will be handling licensing and post marketing activities for the centrally managed medicinal products mainly in the Nicotine Replacement Therapy (NRT) and Gastrointestinal (GI) categories in Perrigo’s International business division (mainly EU) (CSCI)

• Exposure within EU regulatory framework
• Lead regulatory activities for assigned brand(s); providing updates to Category team 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 new MAAs and product lifecycle maintenance activities, identifying risks and opportunities.
• Manage, execute and coordinate new MAA applications and support product lifecycle maintenance activities (including variations, renewals and safety updates).
• Develop, roll out and maintain relevant internal procedures and best practices.
• Maintain the integrity of regulatory data in the relevant databases.
• Carry out any other regulatory tasks as required.
• Support the RA Lead of Cross functional projects across the CSCI business and support on establishing optimized ways of working 
   

Scope of the Role

In this role you will be handling licensing and post marketing activities for the central NRT and GI categories in CSCI.

Main duties and responsibilities include:

• To manage Regulatory Affairs projects as required to meet business needs 
• To ensure compliance with legislation in place for the regulation of medicines 
• To assist in any area of Regulatory Affairs at corporate level 

Experience Required

• Bachelor’s degree in scientific discipline 
• Our ideal candidate should have a minimum of 3 years’ experience in Regulatory Affairs, ideally within OTC, including Post Marketing License Maintenance activities, renewals and safety updates.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work collaboratively under supervision and independently, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Results driven and keen attention to details
• You should be familiar with working in CC-systems (e.g. TrackWise) and eCTD publishing tools.
• While every business thinks it’s different, Perrigo truly is uniquely positioned within healthcare; operating across branded and pharmaceutical environments, with a strong innovation department, all supported by our world-class manufacturing and distribution. All Perrigo employees are expected to live the Perrigo company values.