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Senior Consultant Regulatory Affairs Labelling (m/f) - Berlin
12-12-2018

#Senior Consultant Regulatory Affairs Labelling (m/f) - Berlin

About us

Xendo is a leading consultancy and project management organisation in the fields of (bio) pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.

Over 240 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum. They do so from our headquarters in the Netherlands or offices in Germany and Sweden.

Responsibilities

  • Regulatory and medical writing of CTD-Modules 2.5, 2.7, 5
  • Preparation and submission of applications for marketing authorisations and variations including handling of deficiency letters for human medicinal products
  • Providing regulatory advice in regards to pre- and post-marketing issues to clients
  • Review of promotional materials (Informationsbeautragte), §74a AMG
  • Communication with regulatory authorities
  • Preparation of briefing documents for scientific advice procedures
  • Preparation and translation of product information texts including linguistic review procedures
  • Preparation and submission of variations for medicinal products
  • Project Management

Profile

  • You, ideally hold a Ph.D. in Pharmacy, Biology, Veterinary or Human Medicine.
  • You have proven experience in Regulatory Affairs or Medical Writing.
  • You are good in writing scientific and technical texts.
  • You are ready to take over the role of Information Officer for clients.
  • You are able to maintain high quality, accuracy and consistency in your work and deliver on your commitments.
  • You have a positive attitude and are able to work well within a
  • You are able to work independently with less supervision, take initiative and make decisions based on company guidelines.
  • You are able to work on multiple projects, prioritize and meet project deadlines.
  • You are an excellent communicator and have the ability to work with all levels of the company.
  • You can transfer knowledge to others and teach them abilities based on a coherent educational programme.
  • You are well organized and pay attention to detail.
  • You have outstanding German and English skills.

We Offer

  • A diversity of interesting projects regarding different products with different clients
  • A flexible, dynamic and pleasant work atmosphere
  • Opportunities for learning and further development
  • Good terms of employment

If you are interested in this position, please send your complete application to Vivian Maumo-Ney: In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application!


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