Regulatory Affairs Specialist: Global Compliance Expert

1 giorno fa


Milano, Lombardia, Italia Healthcare Businesswomen'S Association A tempo pieno

Healthcare Businesswomen'S Association is a leader in the Generic and Biosimilar medicines sector, touching the lives of almost 500 million patients annually. We're now seeking a skilled Regulatory Affairs Specialist to join our team and play a crucial role in shaping the future of our organization.

**Job Summary:**

We are looking for an experienced Regulatory Affairs Specialist to support our Country Regulatory Affairs activities at the Sandoz level. As a key member of our team, you will be responsible for executing specific regulatory affairs tasks, maintaining registered products, and supporting project execution.

**Key Responsibilities:**

  • Ensure regulatory compliance with local health authority legislation and expectations.
  • Maintain registration files, including product-related text translations and updates to regulatory databases and plans.
  • Guarantee timely creation and translation of official product information, including Patient Information Leaflets and Summary of Product Characteristics (SmPCs).
  • Support internal and external audits and health authority inspections at country level.

**Requirements:**

  • Bachelor or Master's degree in Bio-Medical / Life Sciences / Pharmaceutical sciences.
  • At least 1 year of relevant work experience in a highly regulated environment.
  • Fluency in Italian and English (verbal and written).
  • Excellent planning, organizational skills, and attention to detail.
  • Result-oriented and accountable for actions.

**What We Offer:**

  • A competitive salary of $80,000 - $100,000 per annum, depending on experience.
  • Customized development paths and access to our on-demand training catalogs.
  • Job rotation projects that allow collaboration with global teams.
  • Corporate Welfare Plan and Recognition Program.
  • Hybrid Work Model based on flexibility and trust.

Join us in shaping the future of Sandoz and helping more patients gain access to low-cost, high-quality medicines sustainably.



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