Regulatory Affairs Specialist
4 tygodni temu
We are seeking a highly skilled Regulatory Affairs Support professional to join our international Regulatory Affairs Team at an international pharmaceutical company.
Key Responsibilities:
- Provide Regulatory Affairs support with the assembly, transmission, storage, and handling of regulatory information.
- Enter document metadata into electronic systems for retrievability.
- Search for documents in non-regulatory systems and copy them for inclusion into regulatory systems.
- Perform special projects as assigned.
- Gather records for transfers, migrations, etc.
- File necessary regulatory records.
- Box records for transfer between sites.
- Scan and perform quality control of scanned images.
- Box records and send to off-site storage.
- Recall boxes from off-site storage.
- Quality control the contents of off-site storage records.
Requirements:
- Experience in a similar position in the pharmaceutical or cosmetics industry.
- Higher education: pharmacy, bioscience, or similar.
- Fluent knowledge of English and Polish (level C1/C2).
- Regulatory/medical/pharma knowledge or a background in information/library science.
- Accuracy, punctuality, meticulousness.
This job offer is intended for people over 18 years of age.
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