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

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. 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 legal 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%

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