Regulatory Affairs

The role involves preparing, reviewing, and maintaining high-quality regulatory documentation to support clinical development activities and product approvals. The Regulatory Affairs professional will monitor and interpret relevant regulatory requirements, advise internal teams on compliance obligations, and support the development of regulatory strategies for multiple regions. Day-to-day tasks include coordinating regulatory submissions, tracking approval timelines, liaising with regulatory authorities or partners, and ensuring that clinical supply chain operations meet applicable regulations. The role also requires close collaboration with cross-functional teams such as clinical operations, quality assurance, and supply chain to mitigate regulatory risks and support timely study execution.
Qualifications
Strong knowledge of Regulatory Affairs and Regulatory Requirements, with the ability to interpret and apply guidelines across different regions.
Hands-on experience with Regulatory Submissions and Regulatory Documentation, including drafting, reviewing, and compiling dossiers and supporting materials.
Demonstrated understanding of Regulatory Compliance principles, quality standards, and good clinical practice related to clinical trials and clinical supplies.
Bachelor’s or master’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline.
Experience in biopharmaceutical, biotechnology, medical devices, or clinical research organizations is highly beneficial.
Strong attention to detail, analytical thinking, and organizational skills, with the ability to manage multiple projects and deadlines.
Effective written and verbal communication skills, including the ability to work collaboratively with cross-functional and global teams.

Work arrangement
No