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An opportunity arisen to work for a well establish company in the NW area. This position involves supporting the development of a pipeline of generic pharmaceuticals
Responsibilities
- Liaise with the QA department and the manufacturing and development sites to get the required data to populate the dossier
- Provide strategic regulatory advice on development projectsPrepare scientific advice requests and attend meetings with MHRA and other national competent authorities
- Write Module 1 and Module 3, Prepare Module 2, Prepare MAA (dossier)
- Liaise with clinical consultants to prepare the non-CMC parts of the dossier
- Prepare associated regulatory submissionsManage regulatory procedures at both EU and UK national level from application through to approval
Qualification and experience
- Successful candidate will have minimum BSc in Life Sciences, Chemistry or related discipline with 4 years’ experience in Regulatory affairsGood Knowledge of Clinical development activities would be desirable Experience with generic drug development programmesPre and post marketing experienceStrong communication skills (both written and orally)
- Attention to detail
- Efficient and timeline/target orientated
- Ability to work both independently and within a team
To apply for this position, candidates must be living in the UK eligible to work
