Manager Regulatory Affairs CMC (m/f)

full-time


Mehr Jobs von HR Consulting - Gerda Zeman
Kontakt: Gerda Zeman-Steyrer
Email: hrconsulting@gerdazeman.at

Manager Regulatory Affairs CMC (m/f) – full-time – location Vienna

Our client is an international clinical-stage biotechnology company. For the Vienna site we are looking for a Manager Regulatory Affairs CMC (m/f) on full-time basis. Our client´s main focus is on Research & Development of new chemical entities (NCEs) for human use to treat indications with high unmet medical need. The company is currently prospering and growing. If you want to be part of this thrilling and at the same time challenging innovative world, here is what we offer.

Our offer

  • Highly responsible and diversified position in a well-established international biotech company
  • Innovative and professional scientific work surrounding
  • Possibility for personal development and growth
  • Room to actively take part in the company´s future while bringing in one´s experience and passion
  • Dynamic and flexible corporate culture
  • Familiar working atmosphere
  • Flexible working times
  • Competitive remuneration

Responsibilities

  • Creating and writing Module 2 and 3 CTD documents
    • NDAs and MAAs
    • INDs and IMPDs
    • Briefing documents and meeting requests
  • Organizing and overseeing the regulatory submission process
  • CMC component writing and review of clinical protocols and reports
  • Representing CMC regulatory internally and externally including regulatory agencies
  • Evaluating and improving existing CMC regulatory risk strategy and making recommendations to the management
  • Keeping up to date with global CMC regulations – making recommendations for any development changes
  • Supporting CMC group in daily business, e.g. managing projects with external CMOs

Qualifications

  • University degree (PhD) in Chemistry, Pharmacy or in a related field
  • Minimum of 5 years in a CMC Regulatory Affairs function with experience on NDA and MAA submissions
  • Proven track record in Module 2 and 3 CTD regulatory submissions, i.e. CMC regulatory lead in at least one successful NDA / MAA submission
  • Substantial experience with eCTD submissions and related submission tools
  • CMC background in drug development and management of CMOs
  • Ability to quickly step into a new drug area and take over responsibility for CMC
  • Passion for organizational and coordinative tasks including good sense for priorities
  • Distinctive project management knowledge and profound problem solving skills
  • Good understanding of multidisciplinary complexity
  • Strong team player with excellent interpersonal skills for necessary collaboration between CMC, Regulatory and Quality
  • Very good organizational as well as negotiation and communication skills
  • Motivated and mature personality
  • Highly reliable and responsible person
  • Fluency in English is required, German is a plus

The minimum salary for this position in accordance with the “Austrian Collective Agreement for the Chemical Industry” is € 4.744,54 gross per month, but will be overpaid depending on the actual qualification of the candidate. We explicitly express our client´s willingness to offer a competitive salary in line with the market and considering your qualification, experience and individual competencies.

Does our description meet your expectations concerning your next career step? Then please send us your CV plus an informative motivation letter and convince us that you are the best candidate for this position. We are looking forward to receiving your application at hrconsulting@gerdazeman.at.  


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