Senior Associate
Full-time, Contract
Job Description
- Document management including uploading and tracking regulatory files and systems according to established procedures and regulatory requirements
- Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
- Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
- Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
- Provide support across the business for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
Required Knowledge, Skills, and Abilities
- Relevant qualification and/or experience in science, administration or IT
- Relevant experience from biopharmaceutical industry, or other relevant experience
- Some regulatory/medical/technical experience
- Project Management skills
- Experience in document management and tracking databases
Reference no: 93701