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Regulatory Compliance Manager CMC

Job description

As Regulatory Compliance Manager you will:

  • Define regulatory filing requirements 

  • Plan activities, coordinate with internal and external partners, supervise the contract developers and contract 
manufacturers 

  • Proofread and check documents for accuracy and inconsistencies 

  • Manage the preparation, writing and functional review of global CMC documents (modules 3 and 2.3) for new 
marketing applications, responses to health authorities and post-approval variations 

  • Respond to regulatory agency questions 

  • Provide support to non-EU clients registration procedures, from due diligence to lifecycle activities 

  • Maintain product compliance through appropriate regulatory filings and activities 

  • Liaise with other project team members and departments to ensure alignment of global regulatory strategies, 
timing, execution and plans 

  • Enter data into company data base/reporting system and ensure information is current 

Skills and personality
  • Strong educational background (MSc or higher in life science) 

  • At least 6 years of pharmaceutical industry experience including at least 3 years of Regulatory Affairs CMC 
experience 

  • In-depth knowledge of EU regulatory requirements (knowledge of US regulatory requirements will be an asset) 
and understanding of the end-to-end drug development process 

  • Solid experience in CTD module 3 handling and life-cycle management of marketing authorisation applications 

  • Strategic thinking, strong problem-solving and analytical skills 

  • Understanding the scientific principles and regulatory requirements 

  • Detailed oriented 

  • Strong communication skills 

  • Strong sense of planning and prioritization 

  • Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural 
environment 

  • Fluent English, both written and oral 

Contract

Executive search

Experience

+- 5 year to 10 years

Education

Higher Scientific Degree

Languages

English

Sector

Pharmaceutical industry

Region

Anderlecht

Job type

Full-time

 
 

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