FREELANCE: Regulatory CMC Manager
- Employer
- Umbilical Life
- Location
- Switzerland
- Salary
- Excellent Hourly Rate
- Start date
- 18 Sep 2019
- Closing date
- 18 Oct 2019
View more
- Discipline
- Regulatory Affairs, CMC, Compliance, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
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
Company
Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering.
Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.
With nearly 75 years of workforce industry experience between us we know a lot, but not everything.
We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.
- Website
- http://umbilical.co/
- Telephone
- 011 6 461 0070
- Location
-
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom
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