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Regulatory Affairs Project Manager Clinical Chemistry and Immunoassays

Green Oaks, IL

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At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. JOB DESCRIPTION: Primary Job Function: As an individual contributor; the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific; regulatory and business issues to enable products that are developed; manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed; obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: u2022 Develop new regulatory policies; processes and SOPs and train key personnel on them u2022 Evaluate regulatory risks of division policies; processes; procedures u2022 Provide regulatory input to product lifecycle planning u2022 Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management u2022 Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes u2022 Assist in regulatory due diligence for potential and new acquisitions u2022 Utilize technical regulatory skills to propose strategies on complex issues u2022 Determine submission and approval requirements u2022 Identify emerging issues u2022 Monitor trade association positions for impact on company products u2022 Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams u2022 Recruit; develop and mentor regulatory professionals u2022 Assess the acceptability of quality; preclinical and clinical documentation for submission filing u2022 Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions u2022 Compile; prepare; review and submit regulatory submission to authorities u2022 Monitor impact of changing regulations on submission strategies and update internal stakeholders u2022 Monitor applications under regulatory review u2022 Communicate application progress to internal stakeholders u2022 Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities u2022 Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies u2022 Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval u2022 Provide strategic input and technical guidance on regulatory requirements to development teams u2022 Manage and execute preapproval compliance activities u2022 Oversee processes involved with maintaining annual licenses; registrations; listings and patent information u2022 Ensure compliance with product post marketing approval requirements u2022 Review and approve advertising and promotional items to ensure regulatory compliance u2022 Ensure external communications meet regulations u2022 Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events u2022 Actively contribute to the development and functioning of the crisis/issue management program u2022 Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies u2022 Report adverse events to regulatory agencies and internal stakeholders u2022 Provide regulatory input for product recalls and recall communications Supervisory / Management Responsibilities: Individual provides leadership without direct authority (, project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues; and must assure that deadlines are met. Effectively communicate; prepare; and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs. Minimum Education: Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience / Training Required: 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry (, medical products, nutritionals). Preferred Qualifications: 5 years of experience in regulatory and 3 years in science such as research and development/support, scientific affairs, operations, or related area preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.u00a0 JOB FAMILY: Project Management DIVISION: ADD Diagnostics LOCATION: United States > Abbott Park : AP08/A Floor-1 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected : :

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