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Senior Consultant – Regulatory CMC (Berlin office)
12-12-2018

#Senior Consultant – Regulatory CMC (Berlin office)

Xendo's German office in Berlin is looking for a new colleague to join the RA CMC team. Specifically, we're looking for someone who enjoys engaging in different projects in the pharmaceutical industry and to assist our clients in fulfilling their business needs. If you have experience in a this (or a similar) field, are open minded, result- and solution-oriented and possess good interpersonal skills, please contact us. 

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 CMC writing of CTD-Modules 2.3 & 3
  • Providing regulatory advice in regards to pre- and post-marketing issues to clients
  • Preparation and submission of applications for marketing authorisations and variations including handling of deficiency letters for human medicinal products
  • Communication with regulatory authorities
  • Preparation of briefing documents for scientific advice procedures
  • Managing projects and project teams
  • Maintaining and building client relationships

PROFILE

  • You, ideally hold a D. in Chemistry, Biochemistry or Pharmacy.
  • You have proven experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs.
  • You have an excellent understanding of the pharmaceutical product lifecycle.
  • You have extensive experience in preparing documentation for regulatory authorities.
  • You are able to maintain high quality, accuracy, and consistency in your work and deliver on your commitments.
  • You are willing to undertake business travels to clients and other Xendo sites.
  • 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 have excellent 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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