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Regulatory CMC Strategist

Company: Katalyst Healthcares & Life Sciences
Location: Jersey City
Posted on: April 3, 2021

Job Description:

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Title: Regulatory CMC Strategist Remote Job Requirements:
    • Provide recommendations about regulatory strategy and general regulatory affairs guidance
    • Provide recommendations regarding investigational and marketed application strategy and document preparation, such as letter requests, agency requirements, briefing document and agency comments
    • Provide recommendations regarding application requirements, content strategy, preparation and regulatory compliance
    • Assist with agency responses
    • Provide responses to ad hoc questions about document content, regulatory submission/content strategy and/or provide general regulatory affairs guidanc
    • Interpret CMC regulatory requirements, develops strategies, assess risks and develops contingency proposals with minimal supervision. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
    • Responsible for the authoring of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control
    • Serve as a CMC strategist and project leader, providing regulatory assessments and developing regulatory strategies with minimal supervision.
    • Act as the global CMC representative, or contributes support to the global CMC representative, within cross-functional project teams. Accountable for assigned projects and activities, completing work within assigned product portfolio, work group/project teams, for multiple projects with minimal supervision.
    • Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring compliance. Develops initial resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Displays a willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
    • Train and GMP regulatory requirements and modern Quality Management System.
    • Must have Brazil, Peru, Argentina, Mexico and Asia Pacific knowledge Desired Education:
      • Bachelor's degree required. Science, engineering or related field (advanced degree preferred) Desired Experience:
        • At least seven (7) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields. Additional Information All your information will be kept confidential according to EEO guidelines. Other jobs at Katalyst Healthcares & Life Sciences

Keywords: Katalyst Healthcares & Life Sciences, Jersey City , Regulatory CMC Strategist, Other , Jersey City, New Jersey

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