RA Executive

Job Description

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines