Senior Regulatory Operations Associate

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 develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

Responsibilities

• Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time in accordance with eCTD submission requirements.
• Works with the Manager as well as document authors or leads across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
• Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
• Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
• Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures that all functional disciplines are apprised of the changes and trained accordingly.
• Helps to author, develop and/or collaborate on SOPs and Work Instructions for the eCTD Publishing and/or Electronic Document Management System.
• Independently track and manage all correspondence between Breckenridge and government agencies, including phone calls, emails, and relevant documents.
• Accurately update and maintain trackers, spreadsheets and databases in a timely manner.
• Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
• Monitors and maintains the highest level of eCTD submission standards.
• Trains new employees in company submission processes and procedures.
• Performs other related duties as assigned.

Qualifications

• Bachelor’s degree in a scientific discipline.

Required Skills

• 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.

At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

Pay range and compensation package

• Flexible approach to how we work
• Health benefits and time-off programs
• Competitive compensation packages
• The anticipated annual salary for this role is $115,000 - 135,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.