Regulatory Affairs Manager
2 weeks ago
- Offer regulatory insights to product development teams for designated brands,
- encompassing claim validation, label assessments, and guidance on regulatory filings.
- Prepare and manage NDA supplements and/or 510(k) submissions along with other regulatory documents for designated brands and products.
- Assist in the enhancement and enforcement of Regulatory policies, focusing on adherence to the company's Quality System, external regulatory benchmarks (e.g., ISO 13485), and pertinent regulations.
- Track global regulatory changes impacting products through engagement in industry associations, monitoring newsletters, government websites, and other resources, and relay significant matters to management.
- Ensure that the efforts of assigned industry task forces and committees align with strategic priorities.
- Extensive experience with U.S. drug and/or medical device regulatory submissions and ongoing maintenance; OTC experience preferred.
- Strong understanding of OTC drug and device regulations, including labeling mandates.
- Familiarity with U.S. clinical research and claims support processes.
- Exceptional written and verbal communication abilities.
- Proven capability to collaborate effectively and positively with colleagues.
- Over 6 years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs.
- Experience in drug or medical device submission and/or maintenance.
- The Regulatory Affairs Manager will support Operations, Quality, Graphics,
- Packaging, Product Development, Legal, and Marketing departments.
- Act as the regulatory representative on designated product development teams.
- Create or evaluate U.S. & Canada regulatory submissions that fulfill company and regulatory agency standards.
- Develop and implement company and departmental Standard Operating Procedures (SOPs) and provide training/compliance support.
- Propose and adhere to realistic timelines for regulatory submissions and approvals.
- Stay informed on changes in regulatory requirements related to OTC drug,
- device, and dietary supplement regulations and communicate these updates within the organization.
- Represent the company on assigned industry task forces and ensure that organizational needs are addressed.
- Enhance work processes for sustained regulatory compliance and departmental efficiency.
- Ensure adherence to applicable U.S. and Canada regulations, laws, and standards.
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