(Senior) Manager Regulatory Affairs Country (m/f/d)

Responsible regulatory support for a defined international country portfolio as well as central contact person in regulatory issues for local partners, authorities and internal stakeholders Development and implementation of country-specific regulatory strategies for new and existing medicines taking into account the respective authorisation, registration and lifecycle requirements Responsibility for the timely planning, creation, coordination, testing and approval of applications and dossiers for international authorisation and registration projects independent processing and expert evaluation of complex administrative requests and deficiencies; Coordination of the required opinions and consistency check of the relevant regulatory documents provided by the participating departments Continuous monitoring of country-specific regulatory requirements and developments as well as evaluation of the impact on the portfolio and ongoing projects Advising internal areas of expertise on country-specific regulatory issues and address-oriented communication of relevant requirements Coordination of cooperation with international partners and interfaces and ensuring consistent and timely regulatory communication Conducting and participating in cross-departmental projects to optimize regulatory processes, documentation standards and internal processes

Successfully completed natural science studies, such as pharmacy, chemistry, biology, biotechnology or a comparable subject Multiannual professional experience in Regulatory Affairs, preferably with responsibility for international markets or country-specific admission and registration procedures in the pharmaceutical industry Knowledge of international and country-specific regulatory requirements and experience in the management of authorisations throughout the product lifecycle Comprehensive experience in the preparation, testing, coordination and submission of regulatory applications and dossiers, as well as in the processing of regulatory requests and deficiencies Experience in cooperation and communication with international partners, local authorities and internal interdisciplinary areas Impressed ability to analyze, evaluate and translate complex regulatory issues into concrete recommendations and regulatory strategies Experience in the independent management and control of projects and in the coordination of various internal and external stakeholders Safe handling of MS Office and ideally experience with regulatory document management systems and databases knowledge of German and English in word and writing; further foreign language skills are advantageous Self-employed, structured and solution-oriented working methods and a high level of sense of responsibility, care and decision-making Embossed communication, organization and stakeholder management expertise and joy in cooperation in an international environment

Varied and versatile topics in a modern, multicultural working environment Flexible working hours and possibility to work on mobile Operating pension: 100% employee-funded pension Health insurance: annual budget of 900 €, e.g. for visual aids, dental care Safe workplace in an attractive, growing company