Regulatory Affairs Project Lead
1 settimana fa
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 enhance the wellbeing of our colleagues and consumers alike by providing The Best Self-Care for Everyone.
We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Job SummaryThis role will be responsible for regulatory activities required to maintain existing commercial products in Consumer Healthcare, Medicinal Products, Food Supplements.
Key ResponsibilitiesRegulatory 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
Requirements
To be successful in this role, you will require:
- 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
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.
Our estimated salary range for this position is $80,000 - $120,000 per annum, depending on experience and qualifications.
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