Arbetsbeskrivning

We are looking for a Regulatory Affairs consultant to our Compliance, Quality and Regulatory team in Malmö! In this role you will work towards diverse goals depending on the client's specific needs. Whether serving as a project leader or strategic adviser, the key element is to drive and support our clients in achieving their quality and regulatory objectives. You will collaborate with major pharmaceutical clients to deliver patient-focused, compliant, and efficient solutions. Your expertise will be crucial in navigating complex CMC regulatory requirements, ensuring that pharmaceutical development meets stringent quality standards from initial research through to commercial manufacturing and product lifecycle management.

Required Experience:

• Degree within Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical engineering or closely related field
• Solid experience within regulatory affairs for the pharmaceutical industry
• Comprehensive understanding in Chemistry, Manufacturing, and Controls (CMC) within pharmaceutical development
• Knowledgeable in preparing comprehensive technical documentation, specifically Common Technical Document (CTD) submissions
• Comprehensive understanding of EU pharmaceutical regulations, encompassing product registration, manufacturing processes, and compliance with EMA guidelines and GxP quality standards
• Fluent in spoken and written Swedish and English

Meritorious:

• Comprehensive understanding of Certification of European Pharmacopoeia (CEP) standards and processes
• Knowledge of US pharmaceutical regulatory frameworks, including FDA guidelines and compliance requirements
• Experience within project management

You as a person:

You are a highly organized professional with proven experience in pharmaceutical regulatory affairs, demonstrating exceptional skills in coordinating and advising. You must be easy to collaborate with, you bring a positive energy and dynamic approach to every challenge. Your communication skills and service-minded attitude make you an invaluable team player who is not afraid of problems but instead sees them as opportunities for innovative solutions. At Capgemini Engineering, we value excellence, care, responsibility, dynamism, and innovation. We offer diverse projects, career development opportunities, and a collaborative environment where your contributions make a difference in advancing healthcare and technology.