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We are seeking a highly skilled Regulatory Affairs Associate to join our central team at Perrigo, supporting life cycle maintenance activities in medicinal portfolios across the EU. This role involves ensuring compliance with legislative frameworks and internal policies, working collaboratively with international regulatory authorities.
As a Regulatory Affairs Associate, you will manage projects, prepare and submit product license variations and post-authorisation applications, and support various regulatory and quality areas, including submissions and documentation preparation.
You will maintain regulatory compliance, stay updated on regulatory requirements, and implement necessary changes. Strong background in regulatory affairs and attention to detail are essential.
Key Responsibilities:- Prepare and submit product license variations and other post-authorisation applications in accordance with current legislation.
- Communicate with international regulatory authorities regarding applications and compliance issues.
- Support all central Regulatory lifecycle maintenance activities.
- Assist in the process of obtaining new Marketing Authorisations.
- Support the regulatory intelligence and implementation of changes to legislation.
- Assess the impact of Administrative, Quality and Safety-related change controls and complete any related actions in accordance with procedures in place.
- Bachelor or Master's degree in Medical/Life Sciences, International Law, European Policies or other relevant fields
- Minimum one year experience in a Regulatory environment
- High attention to detail
- Ability to set priorities and handle multiple tasks simultaneously
- Highly driven with enthusiasm to meet requirements and cope under demanding pressure
- Ability to work autonomously and in a team - very good organization of own work
- Being keen on innovation and creative thinking
Perrigo is a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
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