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Regulatory Affairs specialist

Company: Katalyst Healthcares & Life Sciences
Location: Santa Clara
Posted on: November 19, 2022

Job Description:


  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Provide regulatory input to product lifecycle planning
  • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
  • Assist in regulatory due diligence for potential and new acquisitions
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Determine submission and approval requirements
  • Monitor trade association positions for impact on company products
  • Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
  • Recruit; develop and mentor regulatory professionals
  • Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
  • Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
  • Compile; prepare; review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies and update internal stakeholders
  • Monitor applications under regulatory review
  • Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
  • Ensure compliance with product post marketing approval requirements
  • Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
  • Actively contribute to the development and functioning of the crisis/issue management program
  • Provide regulatory input for product recalls and recall communications
  • Report adverse events to regulatory agencies and internal stakeholders
  • Review and approve advertising and promotional items to ensure regulatory compliance

Keywords: Katalyst Healthcares & Life Sciences, Santa Clara , Regulatory Affairs specialist, Other , Santa Clara, California

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