Stellenbeschreibung

Global Regulatory Affairs CMC Manager-Munich-Permanent-€70.000                       My client is an internationally renowned biotech company with Headquarters in Munich. They are recruiting for a Regulatory Affairs Manager specialised in CMC at a Global level: EU and RoW. The ideal candidate will have 2-3 years' experience in CMC, particularly with modules 2 to 5 and will have managed submissions at a global level Responsibilities: ·         In charge of ensuring the regulatory compliance at a national and international level, in accordance with EU and non-EU legislation ·         In charge with maintenance activities: examination of existing authorizations and organisation and management of Variations and Renewals ·         Manage the full CMC compliance process according to the given timelines ·         Will be the interface of cross-functional departments, such as creation and control of packaging texts, labeling, quality, R&D, etc. ·          Organization and coordination of new projects in accordance with the national, EU and RoW legislative standards Requirements:   ·         A good degree in Pharmacy or a Life Sciences related discipline ·         Excellent knowledge of legal regulations with regards to drug approvals ·         Minimum 2-3 years’ experience in a Regulatory Affairs environment: CMC preferred ·         Experience in compliance, particularly Modules 2,3,4,5. ·         Excellent knowledge of technical and functional requirements for National, International areas (EU, Non-EU) ·         Sound knowledge of English and German. Spanish, French, Russian knowledge is highly desired   The company is in continuous expansion and is looking for the right person to join their international team. If you believe that this role is suitable for your experience and career perspective, do not hesitate to apply.