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 reputed company, CA or remotely reputed company reputed company 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 reputed company the Endoscopy Business. You will be responsible for preparing reputed company 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 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, in order to assess regulatory implications for approval. Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to reputed company 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 reputed company 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. reputed company and maintain positive 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 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company, 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)
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