Eugia Pharma is looking for Regulatory Affairs Associates with good experience in US and Canada Market.Job Location : Pashamylaram, Hyderabad Canteen and Transportation facility available JD for US Market Panning, reviewing and submission for assigned ANDA and NDA projects.Excellent drafting skills for FDA Deficiencies with high quality and regulatory standards in response.Evaluation and good interpretation of post approval changes.Submission of Supplements like CBE, CBE-30 and Prior Approval Supplement (PAS), Annual Reports.Review and authorizing regulatory change controls.Knowledge of eCTD, Module 2and 3.Formulate US Regulatory filing strategy for new projects.JD for Canada MarketExperience in Dossier compilation (Injectable & OSD dosage forms) & knowledge of regulatory procedures and guidelines (ICH). Planning, execution and assessment of product life cycle management activities and strategies (LCM & Variation)Review technical documents like Protocols, API & Drug product technical packages, Change Controls etc and prepare technical documents to support regulatory submissionsKnowledge in query response to agencys questions within assigned timelines

Eugia Pharma is looking for Technical Trainers for Different Locations (Hyderabad/Vizag/Jadcherla).Responsibility:To manage the technical training programme for the respective manufacturing site for enhancing employee skills, improving performance and fostering a culture of continuous learning and development throughout the organizationCollaborating with unit site leadership for identifying technical Training needs for each site and help prioritize the topics of training/learning sessions.Collaborating with Site leadership to create/maintain a list of Subject Matter Experts for each site. Coordinating with corporate technical trainer for planning and execution of technical training sessions and mentoring SMEs Identifying and deploying various innovative training methods for effective training. Organize Learning and Development events with the help of outside experts as per organizational needs Conduct applicable training sessions monitor, track and evaluate training programs effectiveness Having passion for learning and skill development.