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Regulatory Affairs Project Manager

1 mese fa

Roma, Lazio, Italia Perrigo A tempo pieno
About Perrigo

Perrigo is a leading player in the European Consumer Self-Care market and the largest U.S. store brand provider of over-the-counter and infant formula. Our mission is to make lives better through trusted health and wellness solutions, accessible to all.

Job Overview

We are seeking a highly skilled Regulatory Affairs Project Manager to join our team. In this role, you will be responsible for the hands-on regulatory activities required to maintain existing commercial products in Consumer Healthcare, Medicinal Products, and Food Supplements.

Key Responsibilities
  • Prepare applications and technical files in support of existing commercial product regulatory maintenance.
  • Support manufacturing and procurement in the management of change to existing commercial products, identifying any changes necessary in regulatory filings.
  • Develop and approve label specifications in compliance with SOPs.
  • Maintain regulatory files and data systems in compliance with SOPs.
  • Represent regulatory affairs in project meetings with both Perrigo staff and external contacts.
  • Support in external suppliers and internal audits.
  • Support the documentary system: updated SOPs in accordance with corporate SOPs.
  • Continuous improvement of department work processes, procedures, and infrastructure.
  • Support in Trackwise complaints handling.
Requirements
  • Degree in Pharmacy, Chemistry, or CTF.
  • Minimum experience of 3-4 years.
  • Fluency in both English and Italian.
  • Experience in medicines, food supplements, medical devices, biocides, and cosmetic products legislation.
  • Willing to learn and participate in Quality and PV Associate tasks.
  • Agile and ability to adapt to changes.
What We Offer

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.

We promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024".