Consultant Regulatory CMC

Consultant Regulatory CMC

ProPharma Group

Netherlands, Sweden or United Kingdom

Job Description

In the role as Consultant Regulatory CMC you will be working on projects from a variety of Pharmaceutical and Biotechnology companies. On the projects you will be dealing with challenging and varied tasks that requires you to be result and client orientated and to display excellent interpersonal skills. At the same time you will have the opportunity to actively participate in the company’s continued development. You will provide services to our clients spanning all aspects of drug development field including regulatory strategy.

These services include but are not limited to:

  • Providing strategic advice related to Regulatory CMC;
  • Writing and reviewing CMC documents;
  • Defining CMC strategy for drug development projects;
  • Participating as regulatory CMC expert in product development teams;
  • Preparing and participating at national and EMA scientific advice;
  • Preparing CMC sections for clinical trial applications, and marketing authorisation applications.

Qualifications

  • Academic degree in a life science field;
  • Minimum 3 years of experience in a CMC position within the pharmaceutical industry or health agency. Additional knowledge about biologics is a plus;
  • Understanding of CMC guidelines and requirements, drug development activities as well as product life cycle management from a regulatory affairs perspective;
  • Project management skills;
  • Excellent communication skills (oral and written) in English and Swedish;
  • Excellent in writing scientific and technical texts;
  • Ability to execute multiple tasks or projects, being able to prioritise and meet project deadlines;
  • Having an open eye for the needs of your customers and the ability to adjust to these needs;
  • Willingness to dig into the details yet keeping an eye on the overall goal of the project.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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