We are looking for a Regulatory Affairs Specialist for one of our clients in the Pharmaceutical Sector.
Skills: Bachelor's/Master's degrees or equivalent experience in scientific studies such as biology, biochemistry, or analytical chemistry.
"Equivalent Experience" may include training as a technician, laboratory technician, or a comparable qualification, combined with relevant professional experience. Professional experience in laboratory diagnostics (R&D, clinical trials, quality control), regulatory affairs, or quality management. Experience in Regulatory, R&D, Quality, Operations, or Clinical Operations, capable of managing moderately complex projects. Good understanding of healthcare regulatory frameworks. Basic understanding of regulatory strategy and its application. IT skills: Proficient in MS Office, databases, and document management systems. Language skills: Good English skills (fluent spoken and written). Tasks & Responsibilities: Regulatory Document and Submission Compilation: Lead the preparation and management of regulatory dossiers and global submission plans for moderately complex products or programs. Teamwork and Communication: Build strong collaborative relationships, contribute to team efforts, communicate clearly, listen effectively, and support knowledge sharing and conflict resolution. External Interface Management: Partner with stakeholders to identify needs and solutions, build strategic external relationships, and support audits. Regulatory Knowledge and Strategy: Develop understanding of healthcare regulatory frameworks (e.g., IVDR) and design regulatory strategies for products of simple to moderate complexity. Stakeholder Management: Manage stakeholder relationships, ensure timely communication, and build trust and collaboration. Decision Making: Address daily tasks independently, identify issues and solutions, and make sound decisions efficiently. Innovation and Problem Solving: Generate new ideas, resolve issues collaboratively, and offer viable solutions leveraging diverse perspectives. VAAC Leadership and Agility: Demonstrate inclusive leadership, initiative, adaptability, integrity, courage, and agility in team contributions. Schedule: 08/09h - 17/18h, Monday to Friday (flexible). 100% remote position. Some business travel may be required. Conditions: Salary package based on profile. Permanent contract. Flexible benefits (medical insurance, public transport ticket, childcare checks). Discounts on gym network (Wellhub). Learning & Development opportunities. Our goal is that you are well in every way!
#J-18808-Ljbffr