Mgr Regulatory Affairs - Mature Products Team

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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.

• 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/Other Markets)
• Provides input to KPI metrics for submissions and approvals
• Other projects and duties as required/assigned.

• Pharm D/MS in a scientific discipline or equivalent education and related experience
• Master s degree in RA/QA discipline, a plus.
• Prior experience in managing life cycle management regulatory activities a plus; Ability to work independently and in a global environment with strong communication skills
• Minimum 10 years pharmaceutical industry experience required; 8+ years Regulatory Affairs experience required with experience in EU/US/Worldwide markets.
• Strong understanding of CMC requirements, with hands on experience in US FDA and EU CP regulatory procedures and submissions.
• Demonstrates an understanding of ICH and Regulatory Guidelines for US, EU markets.
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.