Regulatory Affairs Specialist: Global Compliance Expert
1 giorno fa
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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