Senior Associate, Regulatory Operations

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Associate, Regulatory Operations

Full Time Professional Berkeley Heights, NJ, US

6 days ago Requisition ID: 1024

Salary Range: $115,000.00 To $135,000.00 Annually

About the job

About the Company

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.

Pay range and compensation package

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:

• 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.

Featured benefits

Medical insurance, Vision insurance, Dental insurance, 401(k), Student loan assistance

Requirements added by the job poster

• 3+ years of work experience with Generic Drugs
• 3+ years of work experience with Electronic Common Technical Document (eCTD)
• 3+ years of work experience with Abbreviated New Drug Application (ANDA)