Regulatory Affairs Manager

2 weeks ago


Baltimore, Maryland, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • 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.
Qualifications:
  • 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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