Regulatory Affairs Liason

Job description

Ref: MEC 172

 

The Regulatory Affairs Liaison (specialty CMC) is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for Galapagos’ products, with primary focus on the overall regulatory aspects of clinical trial submissions and a specialty in CMC documentation. The Regulatory Affairs Liason (CMC) is a standing member of assigned clinical working groups and is the primary regulatory liaison with the CMC department.

 

Principal Accountabilities

  • Coordination, preparation, submission, maintenance, and compliance of regulatory aspects in clinical trial applications, with a specialty in quality IMP documentation, in close collaboration with the CMC department and the assigned Regulatory Lead.
  • Assist in the preparation and compilation of scientific regulatory dossiers and briefing packages (e.g. scientific advice, eCTD Module 3, quality IMPD).
  • Regulatory intelligence: Stay current with changes in regulatory CMC requirements and inform and advise the internal organisation and the CMC subteam. Assist in the preparation of regulatory guidance summaries to support and facilitate strategic decision-making.
  • Records Retention: Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
  • Assist in the compilation and implementation of defined procedural documents and processes for the department.

Requirements

Education

University degree in health sciences, pharmacy, biological science, chemistry or related field.

 

Experience

At minimum 5 years of relevant experience in CMC regulatory affairs in a range of projects, and including writing of CMC documents.

Previous experience in the development of fixed-dose combination products is an advantage.

 

General Skills

Demonstrated attitude of reliability and attention to detail. Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success. Professional attitude towards external and internal contacts. In addition, data gathering, problem solving and analytical thinking skills are highly desirable.

 

Communication Skills

Strong verbal and written communicator in English language, multilingual is an asset.