Regulatory Affairs Professional

Job Tasks:

• Provide Regulatory Affairs support with assembly, transmission, storage, and handling of regulatory information
• Enter document meta data into electronic system for retrievability
• Search for document in non-regulatory systems and copy them for inclusion into regulatory system
• Perform special projects as assigned
• Gathering 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:

• Ability to read regulatory health authority submission documents and correspondence to locate specific information and input it into the electronic regulatory system
• Skill in identifying and matching corresponding information within regulatory documentation
• At least 5 years of experience in regulatory, medical, or pharmaceutical fields, or a background in information/library science
• Education: pharmacy, bioscience or similar
• Experience in document archiving is a plus
• Excellent cross-cultural communication skills in English

Offer:

• Opportunity to work for a global Big Pharma company
• Stable job environment
• International team
• Benefits package
• Hybrid or remote job
• Full time remote work on a 12-months project with option for prolongate

The offer applies to permanent work

Manpower (;Agencja zatrudnienia nr 412); to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!