Project Manager Regulatory Affairs (all genders) - (unlimited / fulltime)
AbbVieLudwigshafenUpdate time: April 29,2022
Job Description
About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. In the business unit Regulatory Affairs, we provide regulatory advice and support the organisation with the content of existing marketing authorisations and for products in development phase. Moreover, we support the pharmacovigilance department on safety relevant matters in line with national requirements. Your responsibilities: Obtain marketing authorisations for new pharmaceutical products Maintain marketing authorisations as required Liaise with European Regulatory Affairs and Corporate groups on regulatory matters Liaise with national regulatory authorities as required Comply with the Company’s policies and procedures to assure consistency of the current local prescribing information with the CCDS in order to: Ensure alignment within the organization Meet the expectations of regulatory agencies Implement approved label through defined artwork process Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products, including participation within affiliate Brand Team Main responsibility for arrangement of national Scientific Advice with national Competent Authorities Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable Coordinating the review of parallel import samples Review of promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice Qualifications Master's degree in business administration, pharmacy or comparable qualification Profound experience of working in a regulatory environment Good communication and analytic Ability to thrive in a changing environment and to re-prioritise workload to meet business needs Good project management skills are essential Excellent command in German and English Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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