- The Regulatory Affairs Liaison (specialty CMC) is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for company’s 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.
- 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.
University degree in health sciences, pharmacy, biological science, chemistry or related field.
- 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.
- 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.