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CMC Regulatory Affairs Biologics-Interdisciplinary Job-Strategy

Business Type: Biotechnology Company
Job Type: Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Location: Germany
Reference: 030484
Closing Date: 23/08/19
Job Details:

My client is a Biotech company, who is currently developing new drugs to be submitted on international level.

In order to prepare the relevant dossier, you will daily work cross-functional projects with colleagues from other departments and from the affiliates abroad (No travel activities involved!). Every single day will therefore look quite unique, so that you will very rarely get bored at this job, even on the long-term period. This is the right precondition for planning your long-term career, if you are looking for becoming an Expert of the Large Molecules!

Furthermore, the relatively small size of the company will allow you to work closely with your managers, so that you will also get the chance to learn more about the Registration Strategy. In few years you will boost both your operational and strategy skills, whilst in many companies these functions are quite separated. If you can bring both, then you will significantly multiply your career opportunities, as you will have more chances at once.

Your core activities:

  • Composing the module 3 for the international submissions of Large Molecules drugs
  • Close cooperation with the colleagues from the Development and the External Consultants in order to ensure the correct Registration work-flow
  • Responses to questions from the Authorities
  • Updating the CMC dossiers according to the relevant guidelines

Location: Munich Area

Starting Datum: ASAP

Contract Type: Permanent, Full Time

Salary: Negotiable upon the experience

Your Profile:

  • Experience in composing the Module 3 for Large Molecules Drugs (Biologics or Biosimilars
  • High command of English language
  • Ability to work in Europe without any visa or sponsorship

Happy to recommend someone? If we manage to place your referral, you will get a small thank you gift.

Please be aware that, due to the high number of application, we could be not able to provide you with feedback, if your profile is too much distant from the one described above.

NonStop Recruitment is a Swiss-headquartered, pan-European specialist recruitment consultancy. NonStop comprises a number of brands each covering a particular sector and with teams of consultants focusing on specific niches. NonStop offices across Europe provide licenced contract or labour leasing solutions, as well as permanent recruitment and executive search solutions. We are dedicated to fulfilling the expectations of our customers. Our unique in-house Quality Assurance function builds on and re-enforces a strong culture of ethics and customer service. For more information, see our website

Posted: 16/08/2019 | NPJ Ref: 240363
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