CMC Regulatory Specialist

A global pharmaceutical organization operating in a highly regulated environment, focused on developing, manufacturing, and supplying high quality medicines that meet international health authority standards.

This role supports regulatory Chemistry Manufacturing and Controls activities for pharmaceutical products throughout their lifecycle. The position focuses on planning, coordinating, authoring, and submitting CMC regulatory documentation while ensuring compliance with global regulatory requirements and project timelines.

• Provide regulatory CMC filing support for assigned projects and products
• Plan and coordinate CMC submission activities in line with regulatory requirements
• Obtain and compile required technical and quality data from cross functional teams
• Author and review CMC documentation for regulatory submissions
• Support submission activities and ensure timely delivery
• Respond to health authority questions related to CMC topics
• Address requests from local affiliates for additional CMC information
• Work under guidance while collaborating closely with internal stakeholders

• Educational background in Chemistry, Pharmaceutical Sciences, or Engineering
• Strong experience or exposure to regulatory CMC activities
• Knowledge of global regulatory requirements related to CMC
• Proficiency in MS Office applications
• Strong attention to detail and documentation skills
• Ability to work within structured timelines and regulatory frameworks
• Excellent command of Dutch and English, spoken and written

• Supportive working environment with structured guidance
• Office based or hybrid role depending on project needs
• Exposure to global regulatory submissions and health authority interactions