Executive, Regulatory Affairs- Clinical Research

This role involves preparing, reviewing, and maintaining regulatory documentation for clinical research projects, ensuring alignment with local and international regulatory requirements. The executive will support dossier preparation and submissions, track regulatory approvals, and collaborate with cross-functional teams such as clinical operations, quality, and supply chain. Day-to-day activities include monitoring regulatory changes, supporting compliance audits, coordinating with regulatory authorities or partners, and assisting in the development and implementation of regulatory strategies for clinical trials. The role also requires maintaining accurate records, supporting internal training on regulatory processes, and contributing to continuous improvement of regulatory workflows.
Qualifications
Candidates should possess strong skills in Regulatory Documentation and Dossier Preparation for clinical research and related submissions.
Candidates should possess a solid understanding of Regulatory Requirements and Regulatory Compliance applicable to clinical trials and medical products.
Candidates should possess experience in Regulatory Affairs, including supporting regulatory strategy, submissions, and interactions with authorities.
Relevant educational background such as a degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
Knowledge of global and regional clinical research regulations and guidelines (e.g., ICH-GCP, local regulatory frameworks).
Strong attention to detail, organizational skills, and ability to manage multiple projects and timelines.
Effective written and verbal communication skills, with the ability to work collaboratively in cross-functional teams.

Work arrangement
No