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Essential Experience:This application is best viewed on Google Chrome and Mozilla Firefox. Welcome! Please sign-up / sign-in to access and review opportunities at Piramal Group. This service is set to disconnect automatically after {0} minutes of inactivity. Your session will end in {1} minutes.. Click OK to reset the timer to {0} minutes.. You have been signed out.. This service is set to sign out after {0} minutes of inactivity.. Job Description - Associate Director Regulatory Affairs (2200003K). Job Description. Associate Director Regulatory Affairs-(2200003K). Description. The Associate Director, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care products in North and South America assigned to their direct reports. He/She will be responsible for reviewing all submissions compiled by their direct reports prior to dissemination to Health Authorities, country distributors or external partners. The Associate Director will act as the regulatory representative on multi-disciplinary product and project teams, providing advice on regulatory activities and communicate regulatory requirements, execution pathways and strategies to the Project Team including authoring of Regulatory Strategy Documents (RSDs).. Key Roles/Responsibilities:. The Regulatory Affairs Associate Director is responsible for providing leadership and guidance to a team comprising of Regulatory Affairs Associates and Managers, some of which are located internationally.. Essential job functions include but not limited to:. Interpret regulations, guidelines, and compliance requirements and communicate them to other team members and departments within the organization while demonstrating a high ability to make appropriate decisions.. Act as regulatory representative on multi-disciplinary product and project teams, providing advice on regulatory activities and communicate regulatory requirements, execution pathways and strategies to the Project Team including authoring of Regulatory Strategy Documents (RSDs).. Work closely with internal manufacturing sites and external manufacturing organizations to assess post-approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy.. Manage the assembly, compilation and review of documentation for product compliance, registration and life cycle maintenance.. Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US, EU and International regulations.. Communicate with global regulatory agencies and distributors/customers as directed.. Responsible for reviewing all submissions compiled by direct reports prior to dissemination to Health Authorities, country distributors or external partners.. Demonstrate excellent oral and written communication skills, including editing of documents prepared by others for regulatory submissions.. https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly9lbi16YS53aGF0am9icy5jb20vY29vcG9iX19jcGxfX18yOTJfMjMzMTM0X180OTc/dXRtX3NvdXJjZT1ndW10cmVlJnV0bV9tZWRpdW09ZmVlZCZrZXl3b3JkPQ==&jid=1139890&xid=292_233134

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General Worker Jobs in Bethlehem (7 results)

Results for General Worker Jobs in Bethlehem