Executive, Regulatory Affairs - Clinical Research

This role is responsible for preparing, reviewing, and maintaining regulatory documentation for clinical research projects, ensuring compliance with applicable regulatory requirements in India and international markets. The Executive will support dossier preparation and submissions, assist in obtaining and maintaining approvals from regulatory authorities, and coordinate with internal project teams to ensure that regulatory timelines align with clinical and supply chain plans. Day-to-day tasks include tracking regulatory changes, updating internal processes and documentation, supporting audits and inspections, and collaborating with cross-functional teams such as clinical operations, quality, and supply chain. The role also involves contributing to regulatory strategy for new and ongoing studies and providing clear, accurate regulatory guidance to stakeholders.
Qualifications
Strong knowledge of Regulatory Requirements and Regulatory Compliance relevant to clinical research and medical products.
Hands-on experience with Regulatory Documentation and Dossier Preparation for submissions to regulatory authorities.
Experience in Regulatory Affairs within clinical research, pharmaceuticals, biotechnology, or related sectors.
Ability to interpret and apply global and local regulations, guidelines, and standards (e.g., GCP, ISO norms).
Excellent written and verbal communication skills, with attention to detail and accuracy.
Ability to manage multiple projects, meet deadlines, and work effectively in cross-functional teams.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline.
Prior experience in regulatory roles supporting clinical trials or clinical development programs is preferred.

Work arrangement
No