Das könntest du laut kununu User:innen als Regulatory Affairs Manager:in in Österreich verdienen
The Position
The role involves performing end-to-end regulatory activities for a biologics segmented manufacturing pilot project in China. Responsibilities include recommending strategies for early approvals, supporting policy influencing, interacting with health authorities, and authoring high-quality CMC regulatory documents. The position requires managing regulatory aspects of change control, communicating submission risks to stakeholders, and ensuring compliance with local and global registration requirements.
Requirements
Candidates should hold a Master’s degree in life sciences and possess at least 3 years of experience in the pharmaceutical or biotechnology industry, specifically in CMC, Regulatory, Manufacturing, or Quality. Proficiency in ICH, WHO, and Chinese regulations is essential, with knowledge of FDA/EMA guidelines being an advantage. Experience in generating technical registration dossiers or manufacturing process development is preferred.
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