Stellenbeschreibung

Regulatory Affairs Manager in LATAM Submissions – Munich – Permanent –€80.000 + bonus packageMy client is a family owned company with strong international presence searching  to expand their business worldwide. They are currently looking for an experienced Regulatory Affairs Senior Manager with extensive experience in Latin America submissions, as well as Asia Pacific and North Africa. Responsibilities:Ensure the content and quality of regulatory documentation for International approvals (EU, and ROW region)Organisation and management of Ads, Variations, New registrations and RenewalsAlways meet the project deadlines and prioritise pivotal issues of SubmissionsIn charge of project planning and organising complex projects with the purpose of Global approval. Manage and oversee the coordination and preparation of registration processes for European Region as well as Latin American RegionThe role will also involve department / people management - Overall management of a team of Junior to Senior Regulatory Affairs OfficersRequirements:A good degree in a Life Science-related subjectProficient level of English. Spanish and German   knowledge desiredMinimum 3 years EU and LATAM Submissions experience with management/ supervisory experience.Strong working knowledge of EEA, LATAM, non-EU regulatory requirements and procedures required.This includes good understanding of eCTD requirements.Experience of working in accordance with GXP quality standards.Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business.The company is based in Munich and they specialise in generics/OTC products. They have over 1000 employees in over 25 countries. If you believe that this job opportunity suits your experience and expectations, don’t hesitate to apply.