BrightOwl Loader Loading

Associate Director Regulatory Affairs (m/f) Planegg Germany,  

Posted on : 28 March 2017

Project Description

Your Responsibilities: Act as a key member of the Development Core Team and have responsibility for planning and managing all regulatory activities for assigned product candidates Define global regulatory strategy Develop the regulatory project goals from the overall product development plan Compile and submit IND and clinical trial applications (CTAs) to enable timely start of the clinical trials for the assigned product candidates Organize and drive preparations for meetings and teleconferences with Health Authorities Responsible for developing the target product labelling in close cooperation with, e.g. clinical and commercial functions Provide guidance to other functions to assure clinical trial programs are carried out in accordance with applicable regulations and SOPs. Data from these trials should support product registration Collect, review and analyse Health Authority guidelines, competitor information and regulatory precedents and provide respective advice to the Core Team Provide regulatory risk assessment for development projects Your Requirements: Pharmacist, preferably with postgraduate degree (e.g. Ph.D.) Minimum 8-10 years working experience in Regulatory Affairs in a (bio)pharmaceutical company Sound knowledge of the relevant national and international regulations relating to the development and approval of biopharmaceuticals 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 Thank you for your in


82152 Martinsried/Planegg Germany

Find a Job Find Candidates

Most Recent Searches

Most Famous Searches

You might also like