Regulatory Affairs Specialist

Vor 6 Tagen

Lausanne, Schweiz Agap2 - HIQ Consulting AG Vollzeit

 

 

Main Tasks:

We are seeking a skilled Regulatory Affairs CMC Specialist to join our team of consultants in the pharmaceutical industry. The ideal candidate will support the maintenance of legacy products of our clients by providing regulatory inputs, managing critical variations, and authoring CMC packages:

  • Provide regulatory inputs to support technical functions and ensure compliance with regulatory requirements.
  • Follow up on regulatory strategy execution and submission preparation for critical variations.
  • Author and review CMC documentation, including Modules 2 and 3, and briefing documents.
  • Review and assess source documents to ensure accuracy and compliance.
  • Conduct risk and gap assessments to identify potential regulatory issues.
  • Perform regulatory assessments of change controls and provide guidance on implementation.
  • Collaborate with cross-functional teams to ensure timely and effective communication of regulatory strategies and requirements.

Required Profile:

  • Bachelor’s / Master's degree in life sciences, pharmaceuticals, or a related field
  • Minimum of 5 years of experience in Regulatory Affairs, with a focus on CMC in the pharmaceutical industry.
  • Previous experience in writing Module 3 of regulatory submission
  • In-depth knowledge of regulatory guidelines and requirements for pharmaceutical products (FDA, EMA, ICH).
  • Excellent written and verbal communication skills in English, French is a plus 
  • Swiss or EU nationality, or valid Swiss working permit 

 

Thank you for your interest in the position, please note that only selected candidates will be contacted. 

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