Assistant Manager – Regulatory Affairs (ROW Market)

Roles and Responsibilities

• To prepare New, Renewal dossier and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for China, South Africa , Mexico and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
• To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
• To review of documents for adequacy and accuracy.
• To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
• To arrange the samples as per country requirements.