Regulatory Affairs Project Manager
Rome, IT, 148
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
Scope of the Role
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
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
Benefits
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.
Find out more about Total Rewards at Perrigo.
Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so 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". Find out more here
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
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 #weareperrigo