Senior Regulatory Submissions Specialist – eCTD & FDA

Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents, ensuring timely, compliant publishing.

You will develop and maintain templates, track regulatory records, and collaborate with cross-functional teams to align on FDA/ICH requirements and SOPs.

The role offers a competitive package with flexible work options and comprehensive health benefits.

This role, Senior Regulatory Submissions Specialist – eCTD & FDA at Breckenridge Pharmaceutical, could be your next move.

This is an excellent opening to take on the Senior Regulatory Submissions Specialist – eCTD & FDA role at Breckenridge Pharmaceutical.

As a Senior Regulatory Submissions Specialist – eCTD & FDA, you will play an important part at Breckenridge Pharmaceutical in Berkeley Heights, NJ, United States.

We invite applications for the Senior Regulatory Submissions Specialist – eCTD & FDA position located in Berkeley Heights, NJ, United States.