Regulatory Affairs Senior Associate - Nazareth, België - Perrigo

Perrigo
Perrigo
Geverifieerd bedrijf
Nazareth, België

3 dagen geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter


Beschrijving

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.

Help us do it.


Description Overview:

This role can be based in any of the following locations: Ghent, London, Paris

In this role you will work on Regulatory Affairs projects as required to meet business needs


It will also be crucial to ensure compliance with Cosmetic Regulation 1223/2009/EC & other regulatory requirements and assist in any area of regulatory affairs at central level.

Hybrid Working Schedule, a mix of onsite and remote working.


Scope of the Role:


  • Work as part of a multifunctional team by providing regulatory input to new product development, including artwork approvals, label claims and associated supporting documentation
  • As part of the team support the process of the notification/registration of Cosmetic products
  • As part of the team ensure product notifications/registrations are correct and compliant with the relevant legislation.
  • Participate to category and project meetings
  • Establish, maintain, review, approve and update of Product Information Files in compliance with the Cosmetic Regulation 1223/2009/EC
  • Approve Master Texts, LATs and promotional materials from a regulatory perspective
  • Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory
  • Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage and communicate impact of these changes
  • Provide input for analysis of data and/or management review, if required
  • Assist in the process of reporting and investigating critical nonconformities and opportunities for improvement
  • Support on report and followup of change control / corrective / preventive actions if necessary
  • Assist in performing internal audits, supplier audits and customer audits if necessary
  • Carry out other related regulatory affairs duties as required

Experience Required:


  • Bachelor or Master's degree in International Law, European Policies, Medical/Life Sciences or other relevant fields
  • Postgraduate qualification desirable
  • 2+ years of experience in a relevant regulatory environment
  • Selfmotivated, flexible and open to changing requirements
  • Highly driven with enthusiasm to meet requirements and cope under demanding pressure
  • The ability to work autonomously and in team
  • The ability to lead and support several concurrent projects/products
  • The ability to priorities decisions and activities to ensure efficient use of resources and address critical issues impacting the business
  • Excellent project management and administrative skills
  • Excellent communicator in English. Additional language skills are preferred.
  • Excellent problem solving skills.
  • Passion for products and regulatory compliance management
  • Thorough and focused personality
  • Have a strong entrepreneurial spirit
  • Interested in innovation and creative thinking
  • 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. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in _
    _English__ and _
    _Spanish__ and will be provided in other accessible forms for persons with disabilities._ #DIV

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