This Job Vacancy has Expired!

Regulatory Affairs Manager CMC

Posted on Aug 30, 2019 by Michael Bailey Associates - UK Contracts

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

The leading global pharmaceutical company in Switzerland, has a new opportunity for a Regulatory Affairs CMC manager to provide support to all CMC related tasks.

This is initially 8 months contract role and may be extended, based in the office in Switzerland.

Your other job responsibilities would include:

  • Authoring CMC documentation for HA submission, applying agreed CMC global regulatory strategies, assuring technical and regulatory compliance,
  • Preparing responses to health authority questions during development, registration and product life cycle.
  • Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines.
  • Identifying any issues with source documents, or any other potential issues that may impact submission quality or timelines, as early as possible.

Ideal Background:

  • Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

Requirements:

  • Prior experience in regulatory affairs CMC/Module 3 in drug/biopharmaceuticals
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology, preferably in small molecules.
  • Knowledge of the drug development process is desirable.
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.

Please apply now by sending a word document of your CV or contact Neha Sharma on (see below)

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 750250798

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