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Regulatory Compliance Specialist
vor 1 Monat
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Planet Pharma.
Key Responsibilities- Develop and maintain a solid understanding of regulatory requirements and available guidance documents.
- Assist with planning, scientific writing, and critical reviews of regulatory submissions, ensuring conformance with regulations.
- Provide high-quality written and oral communication skills.
- Lead through ambiguity and make decisions based on regulatory requirements.
- Strong biopharmaceutical or regulatory background.
- Experience in writing "Model 3: Quality" parts of dossiers.
- German language fluency is an asset.
- Attention to detail and ability to interpret, communicate, and strategize.
A competitive salary and benefits package, including:
- $120,000 - $160,000 per year, depending on experience.
- Bonus structure tied to company performance.
