Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, Baltimore, Maryland, United States, 21276
Responsibilities:
Provide regulatory guidance to product development teams for assigned brands,including claim substantiation, label reviews and advice on regulatory submissions.Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products.ssist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company's Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations.Monitor global regulatory developments affecting products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management.Ensure that the activities of assigned industry task forces and committees reflect priorities.Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred.Strong knowledge of OTC drug and device regulations, including labeling requirementsWorking knowledge of U.S. clinical research and claims supportExcellent written and verbal communication skillsDemonstrated ability to work with people in an effective and positive manner.Requirements:
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory AffairsDrug or medical device submission and/or maintenance experienceThe Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics,Packaging, Product Development, Legal and Marketing functions.Serve as the regulatory representative on identified product development teams.Create or review U.S. & Canada regulatory submissions that meet company and regulatory agency requirementsDevelop and implement company and departmental SOPs and provide training/compliance!Propose and meet realistic timelines for regulatory submissions and approvals.Keep up to date on changes in regulatory requirements related to OTC drug,device, and dietary supplement regulations and communicate these changes within the company.Represent company on assigned industry task forces and ensure that company. needs are addressed.Improve work processes for continued regulatory compliance and departmental efficiencies.Ensure compliance with applicable U.S, Canada regulations, laws, and standards.
Provide regulatory guidance to product development teams for assigned brands,including claim substantiation, label reviews and advice on regulatory submissions.Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products.ssist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company's Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations.Monitor global regulatory developments affecting products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management.Ensure that the activities of assigned industry task forces and committees reflect priorities.Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred.Strong knowledge of OTC drug and device regulations, including labeling requirementsWorking knowledge of U.S. clinical research and claims supportExcellent written and verbal communication skillsDemonstrated ability to work with people in an effective and positive manner.Requirements:
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory AffairsDrug or medical device submission and/or maintenance experienceThe Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics,Packaging, Product Development, Legal and Marketing functions.Serve as the regulatory representative on identified product development teams.Create or review U.S. & Canada regulatory submissions that meet company and regulatory agency requirementsDevelop and implement company and departmental SOPs and provide training/compliance!Propose and meet realistic timelines for regulatory submissions and approvals.Keep up to date on changes in regulatory requirements related to OTC drug,device, and dietary supplement regulations and communicate these changes within the company.Represent company on assigned industry task forces and ensure that company. needs are addressed.Improve work processes for continued regulatory compliance and departmental efficiencies.Ensure compliance with applicable U.S, Canada regulations, laws, and standards.