We offer you a lot of opportunities through an application.
We are particularly interested in what is between the lines.
From the application process to the career planning: we can advise you very well.

Your contact:
Marcel Honegger

Marcel Honegger
K├Ągenstrasse 18
4153 Reinach

Tel.: +41 61 205 98 78
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Regulatory Affairs CMC (Associate) Manager (m/f) 100 %

For our client, an international pharmaceutical company in Basel, we are in search for a Regulatory Affairs CMC Manager ASAP until the end of the year with option of extension.

What the company offers you:

  • An international environment
  • Large and diverse infrastructure
  • Interesting and challenging tasks
  • Company easily reachable by car or public transportation
  • Temporary assignment

Your responsibilities:

  • Authoring high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and reg-ulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle
  • Preparing CMC responses to health authority questions during development, registration and product lifecycle
  • Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Identifying content, quality and/or timeliness issues with source documents, or any other po-tential authoring issues that may impact submission quality or timelines, as early as pos-sible
  • Having deep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.

Your profile:

  • Degree in Science or equivalent
  • Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
  • Languages: Fluent English required (oral and written), Intermediate German skills

Welcome to nemensis!

We are looking forward to getting to know you!

Please apply with your CV, all diplomas and working certificates only.

Your contact:

Marcel Honegger
K├Ągenstrasse 18
4153 Reinach

Tel.: +41 61 205 98 78
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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