Regulatory Affairs Project Manager

at  Perrigo

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be 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. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.

DESCRIPTION OVERVIEW

In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products in Consumer Healthcare, Medicinal Products, Food Supplements

EXPERIENCE REQUIRED

• Degree in Pharmacy.Chemistry, 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
  Please note we offer a hybrid working, which involves 2 days working from home and 3 days in the office

Regulatory Affairs

• 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

Quality Assurance

• Support in external suppliers and internal Audits
• Support on the Annual Quality Management Review
• Support the documentary system: updated SOPs and in accordance with corporate SOPs
• Continuous improvement of department work processes, procedures and infrastructure
• Support in Trackwise complaints handling