Regulatory Affairs Senior Associate - Nazareth, België - Perrigo
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.
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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