[Hiring] Staff Regulatory Affairs Specialist, Pharmaceuticals @Stryker

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As Staff Regulatory Affairs Specialist, Pharmaceuticals, on the Pre-Market Regulatory team, you will be supporting fluorescence imaging drug products used in combination with the Open and Minimally Invasive Visualization portfolios within the Endoscopy Business. • Prepare complex submissions pertaining to pharmaceutical product approvals for clinical investigations, commercial distribution and/or new/expanded indications by FDA, Health Canada and other regulatory bodies. • Assess post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments. • Advise personnel on regulatory pathway option(s) and requirements. • Support presentations to health authorities and any related communications. • Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/background, classification, disease, and/or harmonized/recognized standards. • Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications. • Prepare submissions and/or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/or commercial distribution, such as: CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc. • Ensure that the quality, nonclinical and/or clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory pathways, clarification, and follow-up of submissions under review. • Advise personnel on regulatory requirements for quality, nonclinical and clinical data requirements for clinical study applications and/or marketing applications. • Contribute to evaluations of the regulatory environment and provide regulatory input to product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. • Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities. • Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures. Qualifications • Bachelor’s Degree • 4+ years of experience in an FDA regulated industry • 2+ years of pre- and/or post-market Regulatory Affairs experience • Experience preparing submissions and/or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/or commercial distribution • Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively • Ability to understand and explain detailed regulatory compliance programs and/or issues • Adaptable to a fast-paced environment with changing circumstances, direction and strategy Requirements • Preferred Bachelor's Degree in Health Science or equivalent focus • 4+ years of regulatory affairs experience within pharmaceuticals • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred. Benefits • $95,700 - $207,400 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. • Travel Percentage: 10%Apply Now

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