Regulatory Affairs Project Manager
4 settimane fa
Overview of the Role
As a Regulatory Affairs Project Manager at Perrigo, you will be responsible for maintaining existing commercial products in Consumer Healthcare, Medicinal Products, and Food Supplements. This role requires hands-on regulatory activities, including preparing applications and technical files, supporting manufacturing and procurement, and developing label specifications in compliance with SOPs.
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
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
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
Working Arrangements
Perrigo offers a hybrid working arrangement, which involves 2 days working from home and 3 days in the office.
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