Senior Regulatory Submissions Specialist – eCTD & FDA

Breckenridge Pharmaceutical; Berkeley Heights (NJ); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Flexible work approach

Health benefits

Time-off programs

Competitive compensation packages

Job summary

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.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations.
• Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools.
• Working knowledge of US FDA (OGD/CDER) e-submission requirements.
• Strong written and verbal communication skills.
• Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.

Responsibilities

• Publishes US Regulatory Submissions to the FDA: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, etc.
• Develops and maintains a comprehensive set of e-submission templates compliant with FDA/ICH.
• Maintains tracking mechanisms for regulatory information and archiving records.
• Works on document workflows for submission authoring, review, and publishing.
• Trains new employees on submission processes and procedures.

Skills

Regulatory affairs

eCTD publishing

EDMS technology

FDA eSubmissions

Communication skills

Office software

Education

Bachelor's degree in science

Tools

eCTD publishing software

Microsoft Word

Adobe Acrobat

Microsoft Office Suite

Job description

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.