Specialist, Regulatory Affairs

This role is responsible for preparing, reviewing, and maintaining regulatory documentation related to clinical development projects and medical supplies. Day-to-day tasks include interpreting and applying regulatory requirements, supporting regulatory submissions to relevant authorities, and ensuring ongoing regulatory compliance across regions. The specialist will collaborate with project management, clinical operations, and supply chain teams to anticipate regulatory risks and support strategies that align with global standards.

Additional responsibilities may include tracking regulatory changes, contributing to regulatory process improvements, and providing guidance to internal stakeholders on regulatory affairs topics.

Qualifications

• Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions for clinical development and medical products.
• Candidates should possess strong skills in Regulatory Compliance and Regulatory Requirements, with the ability to interpret and apply global and regional regulations.
• Candidates should possess strong skills in Regulatory Affairs, including experience working with health authorities and regulatory bodies.
• Experience in clinical research, pharmaceuticals, biotechnology, or medical devices is highly desirable.
• Bachelor’s or Master’s degree in life sciences, pharmacy, biomedical engineering, or a related field is preferred.
• Strong attention to detail, analytical abilities, and organizational skills.