Director, Global Regulatory Affairs – CMC (1 of 2)

Updated: April 11, 2024 06:33 AM GMT

Johnson & Johnson

Beerse

Job Description:

Description

Janssen Research & Development, LLC, is recruiting for a Director, Global Regulatory Affairs – CMC (1 of 2). This position can be located in the United States (Springhouse, PA; Horsham, PA; Raritan, NJ; Titusville, NJ); or Europe (Leiden, Netherlands; or Beerse Belgium).

Key Responsibilities:
• The CMC Regulatory Affairs Director is responsible for developing and driving global CMC regulatory strategies as well as other listed responsibilities:
• Develop and execute global CMC regulatory strategies for one or more drug and/or biologic product(s), which may include delivery devices.
• Responsible for the preparation or oversight of regulatory dossiers for submission to Health Authorities.
• Develop and drive consensus on regulatory CMC strategies for Health Authority responses, as needed.
• Supervise and provide leadership and oversight for a CMC RA team that develops and drives global CMC regulatory strategies for multiple products across their... More Detail