A global pharmaceutical company is looking for a regulatory affairs officer to join their dynamic team. You will be responsible for a vast portfolio of licenced pharmaceuticals and a non-pharma range.
1. To support the Regulatory Team Leader ensuring the company, including its various company entities, is fully compliant with its responsibilities for licensed pharmaceutical products.
2. To contribute to the regulatory strategy of the company, especially on licence submissions and complex variations.
3. As appropriate, to act as the lead regulatory person liaising with other departments and external bodies on business projects.
4. Compile and submit variations (MRP/DCP/National) in line with the variation regulation and NCA requirements and in accordance with local requirements.
5. To act as the company representative at appropriate industry regulatory meetings, such as the MHRA, BGMA or PAGB.
6. Support business development function with regard to NPD regulatory project activities and dossier development where necessary.
• BSc in life science discipline or related subjet
• Proficiency in MS Word, Excel and PowerPoint etc. is essential.
• 1-2 years’ experience covering licenced pharmaceuticals would be preferred.
• Experience of interacting with eCTD dossier preparation and licensing databases (FirstDoc/Docubridge/Register) would be preferred.
• Experience of working on life-cycle maintenance regulatory activities for OTC and/or generic products and have DCP/National licence submission would be preferred.
• Experience with pharmaceutical NPD would be preferred.
£25-30,000 plus excellent company benefits including flexi time, a good working environment, statutory pension, a subsidised canteen and 24 days holiday, plus statutory per annum.
Job Ref: 5449