RA CMC Officer

Job description

• Provide timely preparation high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
• Author high- quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines.
• Prepare CMC response to health authority questions during development, registration and product lifecycle
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Identify content, quality and/or timelines issues with source document
• Keep knowledge up to date with regard to regulatory guidelines

Profile

• Master degree in Science (e.g Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent or PhD
• Dutch, English fluent / oral and written
• Regulatory experience preferred, and/or experience in drug/biopharmaceutical
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.
• Ability to critically evaluate data from a broad range of scientific disciplines
• Knowledge of regulatiions, guidelines for NCE’s and product life cycle maintenances is a plus
• Ability to work successfully with extended, multinational project team on multiple projects
• Excellent planning, organizational and interpersonal skills
• Excellent written/ spoken communication and negotiation skills