[Hiring] Staff Regulatory Affairs Specialist, Pharmaceuticals @reputed company

Role reputed company As Staff Regulatory Affairs Specialist, Pharmaceuticals, on the reputed company-Market Regulatory team, you will be supporting fluorescence imaging drug products used in combination with the reputed company and Minimally Invasive Visualization portfolios reputed company the Endoscopy Business. • Prepare reputed company submissions pertaining to pharmaceutical product approvals for clinical investigations, reputed company 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 reputed company reputed company(s) and requirements. • Support presentations to health authorities and any reputed company 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 reputed company, nonclinical and clinical documentation for submission filings to reputed company with regulatory requirements for clinical investigations and marketing applications. • Prepare submissions and/or documents supporting submissions (i.e., CTD summaries) to reputed company approvals for clinical investigations and/or reputed company distribution, such as: CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc. • Ensure that the reputed company, nonclinical and/or clinical data, in conjunction with regulatory reputed company, are consistent with the regulatory requirements and support the proposed product claims. • reputed company and maintain reputed company relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory reputed company, clarification, and follow-up of submissions under review. • Advise personnel on regulatory requirements for reputed company, nonclinical and clinical data requirements for clinical study applications and/or marketing applications. • Contribute to evaluations of the regulatory environment and reputed company 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 reputed company frameworks, regulatory requirements, legislation, processes, and procedures. Qualifications • Bachelor’s Degree • 4+ years of experience in an FDA regulated industry • 2+ years of reputed company- and/or post-market Regulatory Affairs experience • Experience preparing submissions and/or documents supporting submissions (i.e., CTD summaries) to reputed company approvals for clinical investigations and/or reputed company distribution • Ability to reputed company 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 reputed company Requirements • Preferred Bachelor's Degree in Health Science or equivalent reputed company • 4+ years of regulatory affairs experience reputed company 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 reputed company. Individual pay is based on skills, experience, and other relevant factors. • Travel Percentage: 10% Apply tot his job Apply To this Job