Katalyst Healthcares & Life Sciences
Regulatory CMC Consultant
Katalyst Healthcares & Life Sciences, King of Prussia, Pennsylvania, United States,
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr