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Staff Regulatory Affairs Specialist (Remote Optional)

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Company :
CareFusion

Location :
Vernon Hills, Illinois

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

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Description :
Job Description Summary Job Description This role will support various products in the Infection Prevention platform and will complete US regulatory drug applications as needed. Reporting to Associate Director, Regulatory Affairs, the Staff RA Specialist is responsible for supporting regulatory projects in the BDI Surgery Infection Prevention platform. Job responsibilities: – Participate as an active, engaged team member on core projects. – Develop and execute robust regulatory and clinical strategies for both drug and device products. – MaintainU.S. regulatory submission for drug products including NDAs, ANDAs, PAS and annual reports. Responsible for obtaining submission approval including negotiation with regulators in the US. – Liaison with International RA to support global registrations for core projects of new or significantly modified products. – Monitor changes in US requirements andassociated standards. – Review product labeling, advertising and promotional materials – Provide Regulatory support to regulatory inspections, such as ISO and FDA audits. – Participate in cross-functional or cross-business teams to address process improvements, major international regulatory changes or initiatives (e.g., compliance with new registration requirements in developing markets). – Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan. – Ability to travel up to 15%. – Performs other duties and assignments as required. Knowledge and Skills: – Working knowledge of USdrug product regulatory requirements – Demonstrated self-starter, and highly motivated and enthusiastic – Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs. – Ability to be effective in complex projects with ambiguity and/or rapid change – Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators. – Computer literacy (SAP, PC, Microsoft Word/Excel/PowerPoint) – Orientation for detail work product, with emphasis on accuracy and completeness – Familiar with drug development process and design control documents; History Files, Device History Records, QC testing, Stability reports, etc. Education and Experience: – B.A. or B.S. degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.). Advanced degree in life sciences (MS, PhD, etc.) and/or MBA encouraged. Certifications (RAC, CQA, CQM, etc.) encouraged. – Minimum of 5 years directly applicable work experience in a pharma and/or medical technology company. – Minimum of 5 years experience in NDAs/ANDAs/510(k)s/CE Tech Filesfor drug/device products. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #LI-PRO Primary Work LocationUSA IL – Vernon Hills Additional Locations Work Shift