Regulatory Specialist

Added
11 hours ago
Type
Full time
Salary
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Related skills

regulatory affairs pharmacovigilance sop ema gvp

📋 Description

  • Support local implementation of centrally authorized products with EMA coordination.
  • Manage local lifecycle activities (variations, renewals, post-approval changes).
  • Review translated product information texts and packaging for compliance.
  • Collaborate on promotional/non-promotional materials for regulatory compliance.
  • Maintain regulatory documentation and update internal systems.
  • Support PV processes per global procedures and GVP.

🎯 Requirements

  • Bachelor’s or Master’s in pharmacy, Life Sciences or related.
  • 2–5 years of Regulatory Affairs experience in pharma.
  • Experience with promotional material reviews is a plus.
  • Fluent Italian and English (written and spoken).
  • Proficiency in Microsoft Office.
  • Master’s in Regulatory Affairs/Market Access is a plus.

🎁 Benefits

  • Permanent, full-time contract.
  • Health insurance for employee and family (Faschim).
  • Annual welfare plan.
  • Accident and life insurance policies.
  • Short-term incentive plan.
  • Professional development opportunities.
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