Job Description

Job Title: Regulatory Affairs Manager
Location: East Hanover, NJ (Hybrid role!)
Duration: 06 months
Job description:

• Global Program Regulatory Manager Operations Management and Execution Project Management Functional Breadth Cross Cultural Experience Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data. Identification of main HA issues Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in HA interactions to achieve business objectives. Adherence to policy and guidelines Project & stakeholder feedback Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document or their equivalents including identification of gaps or risks in global strategic plan for assigned regions. Partners with regions to align on regulatory strategy in order to fulfil business objectives Implements RFP across assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTA Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g. FDA or EMA). Drives coordination planning and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review. Reviews approves and submits Clinical Trial Applications (CTA and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans.
• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTA Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTA Erroneous decisions result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time human resources and funds; and jeopardize future business activity Contributes to and often leads the development of departmental goals and objectives.
• Directs the development of submission of product registration progress reports supplements amendments and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions.
• Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
• Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations. Coordinates reviews and may prepare reports for submission.

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