About the jobResponsibilities- 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 packageAt 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
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)
