Regulatory Affairs Administrator – Aspen Pharma Group
General Administrative Activities
* Enter and maintain data in electronic systems; ensure electronic information is complete & accurate
* Maintain hard copy filing systems in accordance with established company internal standards
* CPP requests via interactions with Health Authorities
* Arrange for payment of honorariums for external parties, such as notary, experts, translators, etc.
* Maintenance of Admin databases / filing systems
* Population and design of trackers / systems for management reporting
* Inform and communicate to other departments changes to registration status and updates
* Schedule and coordinate meetings, appointments and travel arrangements for RA department
* Prepare agendas for meetings and then record, compile and distribute minutes of meetings.
* Assist with budget related activities
* General clerical duties including photocopying, fax and mailing
* Any other duties as assigned by Head RA in the IRAC team
* Logging the requests in Reg.Intl. Database based on affiliate requests
* Logging the ePIF requests in Reg.Intl. Database based on NoS and NoA
General RA Activities
* Assist with development and maintenance of PIFs (or equivalent document)
* Support in the collection of regulatory intelligence related to CPP’s
* Providing regulatory support and strategy to multi‑disciplinary and inter‑departmental teams
* Assessment and communication of high‑level team workload and activities
* Any other duties as assigned by Head RA in the IRAC team
Regulatory Good Practice
* Perform assigned work in compliance with current legislation and regulatory guidelines
* Contribute to departmental RA knowledge by sharing of knowledge and expertise
Learning and Growth
* Development needs assessed on a regular basis by the individual
* Training and development to be discussed and negotiated with manager
* Learning solutions are identified, proposed and implemented according to development plan
* Attend all assigned training and mentoring sessions
* Complete any other duties as assigned by your Manager
* Minimum 1 year’s experience in a similar role
* Computer literate – MS Office / MS Excel / MS PowerPoint / Web‑based programs (e.g., SharePoint)
* Insight and experience within Pharmaceutical industry an advantage
* Some knowledge of EU regulatory requirements and registration dossiers
* Some knowledge of specific national administrative requirements
* Knowledge of IT tools utilised in an RA department
Seniority level
* Entry level
Employment type
* Contract
Job function
* Health Care Provider
Industries
* Pharmaceutical Manufacturing
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