Job Description

• 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 requirements
• Working knowledge of U.S. clinical research and claims support
• Excellent written and verbal communication skills
• Demonstrated ability to work with people in an effective and positive manner.

• 6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
• Drug or medical device submission and/or maintenance experience
• The 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 requirements
• Develop 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.

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