Beschreibung
You will be responsible for maintaining the product licences in the European Union countries for assigned registered products.Major Accountabilities:
Lead and coordinate timely and high quality preparation of all necessary documentation by internal or external experts for EU license renewals, EU variations, PSUR submissions via Centralized Procedure (CP), Mutual Recognition Procedure/Decentralized Procedure (MRP/DCP) with the support of the respective Reference Member State, National Procedure Interact with the EU and other Rest of World Health Authorities to solve regulatory issues related to assigned registered products, as appropriate. Lead the HA Response Team through the regulatory maintenance processes. Represent RA in negotiations with HA in EU Provide prompt and complete responses to regulatory relevant queries from various stakeholders Partner with US GPRM in preparation of IND/NDA Annual Reports and US PI changes driven by CDS update for assigned Established Medicine brands.
Provide DRA input and collaborate with relevant GLFs, in planning and execution of agreed actions relating to the thorough and efficient management of regulatory procedures across EU, specifically EU referrals and art 45 procedures for assigned EM products.
Provide DRA input for pruning, in- and out-licensing initiatives for assigned Established Medicines, worldwide.
Collaborate with EMBF Global Marketing and relevant GLFs in creating strategies and action plans to ensure the maintenance of product licenses for assigned EM brands, worldwide.
Ideal Background:
Education: University Degree or PhD in Life Sciences, Pharmacy or Medicine
Languages: Fluency in English as business language, additional European languages advantageous
Experience/ Professional requirements:
experience in EU (or global) regulatory affairs, related areas of the pharmaceutics-cal Industry or Health Authorities
Knowledge and experience in management of licenses and variations in EU for established products
Strong experience in management MAA via (CP, DCP, NP, MRP) * Good interpersonal and communication skills, ability to work effectively in a matrix environment
(As per clients requirement this project is offered on payroll basis)
Please send your CV to Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.