Regulatory Affairs Project Manager

2 giorni fa


Roma, Lazio, Italia Perrigo A tempo pieno

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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