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Grifols Shared Services North America, Inc Manager, Regulatory Strategy - CMC in Clayton, North Carolina

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Summary:

Manage, execute, and implement worldwide regulatory product registration strategy and tactical decisions from project inception to regulatory approval. Write and/or evaluate complex chemistry/manufacturing and controls technical and scientific documentation affecting new and/or marketed products.

Primary Responsibilities for Role:

  • Act as Regulatory Affairs authority for specified projects for products/facilities/equipment.

  • Manage and prepare simple and complex submissions that are in compliance with ICH requirements.

  • Collaborate with cross-functional subject matter experts to prepare technical content and/or identify documentation to support responses to regulatory agency inquiries.

  • Collaborate with domestic and international regulatory counterparts as needed to support submissions and obtain input regarding regulatory considerations for products/facilities/equipment projects.

  • Evaluate change requests for local and alternate productions sites for regulatory reporting requirements. Track and complete designated reporting as applicable.

Knowledge, Skills, And Abilities:

  • Proven technical knowledge demonstrating understanding of processes and procedures including manufacturing, testing and other areas to adequately write and review regulatory documents to be submitted to global health authorities based on specific country regulations.

  • Provide regulatory guidance to cross functional teams/departments to determine regulatory strategies to meet business objectives.

  • Ability to prioritize and manage multiple and possibly conflicting priorities.

  • Ability to work independently and initiate and manage contacts essential to submission preparation.

  • Ability to work as part of the regulatory team to meet group objectives.

  • Ability to work with management of other Grifols departments and sites in order to achieve shared business and regulatory objectives.

  • Ability to review a document in detail to ensure accuracy and verify content meets applicable regulatory requirements.

  • Ability to summarize and effectively present complex information verbally and in writing to internal and external audiences, including regulatory authorities.

  • Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and file documents and organize work in a shared environment.

  • Ability to work with other computer systems for source document retrieval and research.

  • Ability to research, interpret and effectively communicate regulatory requirements.

  • Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.

  • Ability to track and proactively meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Requirements:

  • Bachelor of Science degree in relevant discipline, plus:

  • Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience.

  • Experience with a broad spectrum of functions related to the manufacture of biological products including but not limited to general facilities, aseptic filling, validation, environmental monitoring, cGMP manufacturing, QA/QC, compliance, development and/or regulatory is required.

  • Experience with ICH CTD requirements and dossier lifecycle management is preferred.

  • Proven written and verbal communication skills of complex and technical information is required.

  • Knowledge of applicable laws and regulations

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

EEO: Minorities, Women, Disabled, Veterans

Req ID: 255187

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