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Startseite Jobs, Karriere Marketing, Medien, PR (Associate) Director (gn) Regulatory... (Planegg)

(Associate) Director (gn) Regulatory Affairs

(Associate) Director (gn) Regulatory Affairs - Planegg 
Berufserfahrung
erforderlich
Leitungsebene
nicht leitend
Führungserfahru​ng
nicht erforderlich
Arbeitgeber
Inserent ist Arbeitgeber
Jobtyp
Vollzeit
Firma
MorphoSys AG
PLZ der Firma
82152
Ort der Firma
Planegg
(Associate) Director (gn) Regulatory Affairs MorphoSys AG Planegg Assume responsibility for planning and managing all regulatory activities for assigned development program; define global regulatory strategy; develop the regulatory project goals from the overall product development plan;... ' mission is to make exceptional innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases innovative technologies and smart development strategies are central to our approach success is created by our people who focus on excellence in all they do collaborate closely across disciplines we all are driven by a desire to make the medicines of tomorrow a reality guided by mutual respect and trust each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment join us in planegg near munich we would like to fill the following vacancy as soon as possible: (associate) director (gn) regulatory affairs your responsibilities: assume responsibility for planning and managing all regulatory activities for assigned development program define global regulatory strategy develop the regulatory project goals from the overall product development plan lead the preparation and submission of ind and clinical trial applications (ctas) to enable timely start of the clinical trials for the assigned product candidates drive and/or support the preparation of line extensions and/or marketing authorisation applications in europe and usa and other regions when applicable organize drive preparations and conduct meetings and teleconferences with health authorities responsible for developing the target product labelling in close cooperation with eg clinical and safety and commercial functions provide guidance to other functions to assure clinical trial programs are carried out in accordance with applicable regulations and sops collect review and analyse health authority guidelines competitor information and regulatory precedents and provide respective advice to the global project or clinical team provide regulatory risk assessment for his/her development projects manage the regulatory activities related to the maintenance and life cycle management of marketed products when applicable contribute to the setup of the quality management system with regards to regulatory processes your requirements: scientific degree preferably with postgraduate degree (e g ph d pharmd) ideally minimum ten to twelve years working experience in (global) regulatory affairs in a (bio) pharmaceutical company knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals knowledge of co-development of drugs in conjunction with companion/ in-vitro diagnostics is a plus excellent communication skills verbal and written (english and preferably german) ability to organize and carry out diverse activities in a changing environment often under time pressure strong analytical skills to be able to interpret regulatory data and support critical decisions the ability to work within a team framework and a multicultural environment we offer: creative working in x-functional teams open and appreciative corporate culture multicultural environment working in an attractive high-quality equipped building with restaurant free sports and language courses thank you for your interest we are looking forward to receiving your pertinent application docu­ments for your application please use exclusively our career portal wwwcom/careers/job-opportunities we offer not only excellent career prospects but also support you from the very beginning - even helping you move if necessary

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82152 Planegg
82152 Planegg
Anzeigentyp
Gewerbliches Angebot
Anzeigendatum
09.07.2020
Anzeigenkennung
12e3452b
Aufrufe dieser Anzeige
65