Description
This is a great opportunity for someone to come on board to join a company and receive the best insight they can within a generics company. If you feel like you are pigeon- holed at the moment the below job duties will ensure you are not with this company, therefore please read on...Your day to day activities will require:
- Ensure that the company's products comply with the regulations of the Medicines and Healthcare Regulatory Agency (MHRA)
- To ensure the company's manufacturer (MIA) and wholesale dealer (WDL) licenses are maintained and up to date to allow importation and distribution of all company's products
- To support UK and the companies regulatory department for eCTD submissions by either National, DCP or MRP procedures
- To prepare submissions of license variations and renewals to strict deadlines
- To respond to questions from regulatory authorities raised during technical review of submissions, variations and renewals
- To write and review all SOP's within the regulatory department
- To keep abreast of all European regulatory legislation, guidelines and customer practices
- To keep up to date with the company's current and future product range
- To interface all regulatory affairs with the in QA function of the company
- Monitoring and setting timelines for license variations and renewal approvals by reporting to the General Manager on an agreed format and frequency
- To write clear, accessible product labels and patient information leaflets
- To manage the user testing of patient information leaflets when required
- To specify storage, labelling and packaging requirements in accordance with the product licences
- To undertake and manage all regulatory inspections
- To comply with the office policies and and guidelines
To understand more about the role please do call me on alternatively you can email me on l.khan at realstaffing.com