Regulatory Affairs Associate

Regulatory Affairs/Clinical Affairs Nazareth, Belgium


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Global Regulatory Affairs Associate

We are pleased to offer a great new position in our International Regulatory Affairs team. This is a very nice opportunity to join a successful and growing global consumer health care organisation and be part of a diverse and well respected Regulatory Affairs function. The role is based in Nazareth, Belgium.

 

Job Description

To work on global Regulatory Affairs projects supporting business needs in the area of cosmetics including new product developments, roll-outs and maintenance projects.To help ensuring compliance with the EU Cosmetic Products Regulation (EU) 1223/2009 and all other applicable legislation.

Responsibilities 

  • Work as part of a multi-functional team by providing regulatory input to new product development, launches including artwork approvals, label claims and associated supporting documentation
  • As part of the team support the regulatory process of product maintenance including changes
  • As part of the team ensure product notifications/registrations are correct and compliant with the relevant legislation.
    • Create, review, approve and update technical documentation (Product Information File including Claim Support Documents and Cosmetic Safety Reports), ) in compliance with the above mentioned legislations
    • Approve Master Artwork, Master Texts and Local Artwork Translations from a regulatory perspective
    • Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the non-European territories
    • Initiate corrections to Master Documents & Regulatory Affairs Procedures as required
    • Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes
  • Analyze regulatory changes and inform relevant stakeholders of developments in national and EU regulations and legislation
  • Carry out other related regulatory affairs duties as required

Desired Profile

  • ‘Give it a go’ and positive attitude being keen on creative and problem solving thinking whilst being thorough and focussed with the necessary attention to detail.
  • Ability to work on several projects in parallel in a flexible manner both autonomously and in a team environment.
  • Good communication skills.
  • Passion for regulatory affairs

Requirements 

  • Fluent in English
  • Master’s degree in Science, Life Sciences, International Law, European Policies or other relevant fields
  • Hands-on experience in EU cosmetic regulatory affairs is a plus.