Regulatory Compliance Specialist
Há 3 dias
Hovione Overview
We are a family-owned international group of companies dedicated to helping pharmaceutical customers bring new and off-patent drugs to market. With a strong focus on innovation and excellence, we have established ourselves as a leading Contract Development and Manufacturing Company.
Job Description
The successful Regulatory Compliance Specialist will be responsible for implementing and managing quality systems and tools, ensuring alignment with our strategic plan. Key responsibilities include:
- Managing quality systems and tools to ensure compliance with global and local regulations.
- Providing technical support and services to internal and external stakeholders on quality and regulatory matters.
- Representing Hovione in communications with regulatory authorities and professional associations.
Required Skills and Qualifications
- University qualification in Chemistry, Chemical Engineering, Pharmacy, or a related scientific field (mandatory).
- Typically requires 3-5 years of relevant experience in operational areas, preferably in the pharmaceutical industry.
- Strong understanding of quality and regulatory requirements, cGMPs, ICH, CFR, EU, and ISO Standards.
- Fluency in English is essential.
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