Regulatory Professionals are now working with a leading Pharmaceutical company who specialise in the development, registration and international marketing of pharmaceuticals. Due to continued growth they are now looking for a Regulatory Affairs Manager to join there team in the Basel area and take responsibility of submission into the Middle East and African markets.
This position requires someone to take responsibility for the regulatory support of development projects and marketed products for all regulatory topics related to submission and registration. These will be in non-EU countries and will be focused mainly towards the MEA so experience within this market is hugely desirable.
- Define registration strategies for successful submissions and approvals within the MEA and non-EU markets - You will be responsible for ensuring ready to submit packages to sent to the correct organisation or partners in accordance with agreed plans - Ensure submission and approvals in MEA countries including management of deficiency letters - Liaising with local regulatory partners - Work in cross functional teams in particular with the commercial affairs teams - Maintain the registration tracking database and keep an overview of approval status
- University degree in a scientific discipline - Experience within regulatory affairs within the Pharmaceutical industry - Experience working on submission into the Middle East and Africa - Must be able to work in international and cross functional teams - Must be able to speak English fluently - Independent worker
Keywords: Regulatory Affairs, submissions, Middle East and Africa, cross functional teams, non-EU, pharmaceutical