Regulatory Affairs Project Manager, Rome
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Regulatory Affairs Project Manager, RomeClient:Perrigo
Location:Rome
Job Category:Other
EU work permit required:Yes
Job Reference:2c98eb16b0b7
Job Views:2
Posted:08. 02. 2025
Expiry Date:25. 03. 2025
Job Description: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, and Food Supplements.
Scope of the RoleRegulatory 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 model, which involves 2 days working from home and 3 days in the office.
BenefitsWe 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 Perrigo.
Hybrid Working ApproachWe love our offices and the setting they provide for in-person collaboration and celebration.
But we also appreciate the opportunity to work remotely, which can energize you too, so we promote flexibility with the ability to work two days a week from home in many roles.
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.
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.
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