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Regulatory CMC Consultant

Company: Katalyst Healthcares & Life Sciences
Location: King Of Prussia
Posted on: February 25, 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 Responsibilities:
    • Under the guidance of a Global Regulatory Affairs - Biologics CMC Director, the contractor will work within a team to execute regulatory strategies, plan, track, and author and gain approval for global post approval changes.
    • Knowledge of global CMC guidelines regarding post approval changes.
    • Execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines.
    • Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
    • Lead authoring of clear, concise and effective global post approval submissions according to defined timelines.
    • Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
    • Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
    • Participation in early and late development programs may be required.
    • Experience with biological products is preferred but not required. Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Katalyst Healthcares & Life Sciences, Philadelphia , Regulatory CMC Consultant, Professions , King Of Prussia, Pennsylvania

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