Regulatory Affairs Executive

This responsibilites includes preparing and reviewing regulatory documentation and dossiers to support clinical development projects and product approvals. The individual will interpret and apply regulatory requirements, ensure ongoing regulatory compliance, and coordinate submissions to relevant health authorities. Day-to-day tasks include maintaining up-to-date knowledge of regional and international regulations, collaborating with cross-functional teams (clinical, quality, supply chain, and project management), and supporting regulatory strategy for new and ongoing clinical trials. The Regulatory Affairs Executive will also assist in responding to regulatory queries, contributing to internal process improvements, and maintaining accurate regulatory records and tracking systems.
Qualifications
Strong skills in Regulatory Documentation with the ability to organize and present information clearly for regulatory submissions.
Solid understanding of Regulatory Requirements and Regulatory Compliance, including regional and international guidelines relevant to clinical trials and medical products.
Demonstrated experience in Regulatory Affairs, preferably within biopharmaceutical, biotechnology, or clinical research environments.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or a related field.
Ability to interpret complex regulations, analyze risk, and provide practical compliance recommendations to project teams.
Strong written and verbal communication skills, with attention to detail and accuracy in documentation.
Proficiency in using standard office and documentation tools; familiarity with electronic document management systems is an advantage.
Organized, proactive, and able to manage multiple projects and deadlines in a fast-paced, global environment.
Prior experience working with clinical trial regulatory submissions or medical device/drug approvals is preferred.

Work arrangement
No