FREELANCE: Regulatory CMC Manager

Location
Switzerland
Salary
Excellent Hourly Rate
Posted
18 Sep 2019
Closes
18 Oct 2019
Ref
HALLAS/RegCMCMgr-SUI
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

FREELANCE: Regulatory CMC Manager

Switzerland   |   6 months+   |   Excellent Hourly Rate

Jamie Hallas at Umbilical Life has partnered with an ambitious biopharmaceutical company to source a Regulatory CMC Manager to join the client on a contract basis, to write CMC modules and support the regulatory team in answering agency questions.

I am interested in talking to experienced Regulatory professionals, for a confidential conversation call Jamie Hallas on 0044 116 461 0070 or email jamie.hallas@umbilical-life.com

Accountabilties

  • Writing and updating technical regulatory documents for clinical and marketing submissions, including Module 2 and 3 sections
  • Writing and updating IMPD/INDs for clinical trials applications, up to Phase 3 studies
  • Preparing CMC answers to regulatory authority questions, for marketing and clinical applications, and technical variations
  • Assisting Quality Assurance in ensuring GMP and regulatory compliance in all relevant activities

Qualifications

You will have an advanced Life Sciences or Pharmacy degree, as well as;

  • A minimum 3 years’ experience in technical regulatory affairs, within a pharmaceutical or biotechnology company, or a service provider
  • Experience writing Module 2 and 3 sections of clinical and marketing submissions
  • Experience writing quality sections of IMPD/INDs for clinical trial applications
  • Excellent verbal and written English language communication
  • EU citizenship, or a pre-existing right to work in Switzerland

For a confidential discussion please contact

Jamie Hallas at Umbilical Life on

+44 (0) 116 461 0070 or email jamie.hallas@umbilical-life.com

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