Regulatory Affairs Specialist

This role involves preparing, reviewing, and maintaining regulatory documentation to support global clinical development programs and supply chain activities. The specialist will monitor and interpret applicable regulatory requirements, ensure compliance with relevant standards and guidelines, and assist in developing regulatory strategies for clinical trials across different regions. Day-to-day tasks include coordinating regulatory submissions, tracking approval timelines, liaising with internal teams and external partners, and maintaining accurate records for audits and inspections. The role also includes supporting continuous improvement of regulatory processes and contributing to risk assessments related to clinical supplies and trial operations.
Qualifications
Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions for clinical trials and medical products.
Candidates should possess solid knowledge of Regulatory Compliance and Regulatory Requirements across multiple regions and regulatory bodies.
Candidates should possess expertise in Regulatory Affairs, including strategy development and cross-functional collaboration.
Relevant experience in clinical trials, pharmaceuticals, biotechnology, or medical devices is beneficial.
Bachelor’s or master’s degree in pharmacy, life sciences, regulatory affairs, or a related discipline is preferred.
Strong attention to detail, organizational skills, and ability to manage multiple projects and deadlines.
Effective written and verbal communication skills, with the ability to interpret and convey complex regulatory information clearly.
Experience with quality management systems, ISO standards, and global health authority interactions is an advantage.

Work arrangement
Yes