Regulatory Submissions Specialist - eCTD & FDA Expert

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

Benefits offered by this job

Flexible work options

Health benefits

Time-off programs

Competitive compensation package

Job summary

Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records, enabling timely submissions.

The role requires strong communication skills and 5+ years in pharma regulatory affairs, with 3–4 years in regulatory operations. Competitive benefits and a robust team environment are offered.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 5 years in the pharmaceutical industry with 3–4 years in regulatory affairs operations.
• Knowledge of eCTD publishing systems and EDMS technology.
• Working knowledge of US FDA e-submission requirements (OGD/CDER).
• Strong written and verbal communication skills.
• Proficient with Microsoft Word, Adobe Acrobat, and MS Office; eCTD publishing tools.

Responsibilities

• Publishes US Regulatory Submissions to the FDA: NDAs, INDs, ANDAs, amendments, and reports on time per eCTD requirements.
• Develops and maintains e-submission templates compliant with FDA and ICH.
• Maintains trackers for regulatory information and archives records (electronic and hard copy).
• Manages document workflows for submission authoring, review, and publishing.
• Monitors evolving regulatory e-submission requirements and trains staff accordingly.
• Authors SOPs/Work Instructions for eCTD Publishing and EDMS.
• Tracks correspondence between Breckenridge and government agencies.

Skills

Regulatory experience

eCTD publishing knowledge

FDA e-submission knowledge

Strong communication skills

Microsoft Word / Adobe Acrobat

Education

Bachelor's degree in a scientific discipline

Tools

eCTD publishing software

EDMS technology

Job description

Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records, enabling timely submissions.

The role requires strong communication skills and 5+ years in pharma regulatory affairs, with 3–4 years in regulatory operations. Competitive benefits and a robust team environment are offered.