Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)

About the position We are currently seeking a Staff Regulatory Affairs Specialist, Pharmaceuticals to join our Endoscopy Division to be based in San Jose, CA or remotely anywhere within the United States. What you will do 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. You will be responsible for preparing 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. You will assess post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments. You will advise personnel on regulatory pathway option(s) and requirements. You will 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, in order to assess regulatory implications for approval. Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval. 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.

Responsibilities

• preparing 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
• assessing post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments
• advising personnel on regulatory pathway option(s) and requirements
• supporting presentations to health authorities and any related communications
• supporting regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval
• assessing the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval
• preparing 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
• ensuring 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
• developing and maintaining 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
• advising personnel on regulatory requirements for quality, nonclinical and clinical data requirements for clinical study applications and/ or marketing applications
• contributing to evaluations of the regulatory environment and provide regulatory input to product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• demonstrating strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
• possessing and applying a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures

Requirements

• 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 and has the desire to thrive in a dynamic environment

Nice-to-haves

• 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.

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