Description
Regulatory Affairs Officer: Global Pharmaceutical CompanyLocation: Berkshire
Salary: £25K circa
In order to apply you must have, at least 12 months experience within an administrative or regulatory affairs role. Job Function
- To provide technical and administrative support to the UK Regulatory Affairs Department in order to:
- Ensure that the necessary Regulatory support is provided
- Assist the Regulatory Affairs Manager to maintain existing, and obtain new, regulatory approvals in UK and Ireland in support of commercial activities and strategy.
Key Accountabilities
Regulatory:
To assist with the preparation, compilation and submission of a range of regulatory applications including:
- Type I and II variations
- PIL and labelling amendments
- Change of ownership applications
- Renewals
- PSUR submissions
- Marketing Authorisation Applications
- To assist with the preparation and review of updated product information texts and artwork mock-ups
- To help prepare Regulatory Standard Operating Procedures
- To keep abreast of regulatory international legislation and guidelines
- To ensure accurate regulatory records are kept. This includes:
- ensuring the paper filing is kept up to date on a weekly basis,
- overseeing the electronic filing,
- ensuring the archives are efficiently managed,
- administrative support with maintaining and updating of the electronic regulatory database - Register
- administrative support with maintaining and updating the electronic document management system - Mandarin
- coordination of the review of regulatory materials on Zinc to ensure efficient turnaround, certification and withdrawal/recall/re-approval as required.
- maintaining product licence list
- management of the external archiving of regulatory documentation
- Answer routine correspondences on own initiative
- Undertake general duties or projects as required by Regulatory Affairs Manager.
- To manage the administrative aspects of the Regulatory Affairs and Compliance departments and ensuring they are carried out efficiently and effectively. This includes:
- diary control
- booking meeting rooms
- making travel arrangements
- handling incoming and outgoing post
- arranging payment of fees to the Medicines and Healthcare Products Regulatory Agency (MHRA), Healthcare Products Regulatory Agency (HPRA) and other relevant authorities
- dealing with invoices
- maintaining training records for the Regulatory Affairs and Compliance Team relating to training they have received
- Preparing Excel Spreadsheets and Powerpoint presentations as required.
- taking minutes at relevant meetings
If you are interested in this excellent opportunity please contact Natalie Hopkins our Senior Regulatory Consultant on and email your C.V directly to n.hopkins(a)realstaffing.com