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The opportunity
The manager is responsible for the supervision, preparation, and critical review of high quality regulatory submissions to the regulatory agencies within company timelines and in accordance with regulatory guidelines.  The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager will be the product manager for the assigned products and will manage life cycle management activities such as variations, renewals, responses to HA queries and prepare packages for submission to Health Authorities in the required markets. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The product portfolio will cover mature innovative medicines.How you’ll spend your day
Plans Regulatory Submission Tracker of all Life Cycle Management activities Worldwide Markets for the assigned products. 
Prepare submission strategy as per regulatory requirements in the given markets and works with cross functional teams for final package creation.  Manages all operational activities as needed in Teva regulatory systems.
Serves as regulatory representative and works closely with Worldwide markets to ensure timely submission; Maintains collaborative partnerships with stakeholders.
Scope of Life Cycle Management Activities include all variations, renewals, PSURs, DSURs, RMPs and responses to queries from Health Authorities (EU/US/APAC/Other Markets)
Provides input to KPI metrics for submissions and approvals
Other projects and duties as required/assigned.