Senior Associate Regulatory and Business Continuity
$102,500–$125,000 year
HybridAll, Catalunya, Kingdom of Spain
Job Summary
Prepare ANDAs, amendments, and annual reports for FDA compliance while coordinating stakeholder responses to deficiency letters. Review CMC documents for scientific acceptability, manage eCTD and SPL submissions, and conduct GAP analyses to summarize anticipated deficiencies. Maintain regulatory databases, oversee change control processes, and renew establishment registrations with PDUFA program fees. Submit controlled correspondence, manage PLAIR requests, and ensure timely receipt of Certificates of Pharmaceutical Products. Work cross-functionally with R&D, project management, and sites to implement guidance updates and SOPs. Hybrid schedule of three days in office; base salary $102,500 to $125,000.
Required Qualifications
- Bachelor's degree in Pharmacy, Chemistry or life science
- 5-8 years of related Pharmaceutical Industry experience preferably in Regulatory Affairs
- Must be highly organized and have the ability to meet critical timelines
- Very strong organizational skills that is necessary to manage and multi-task various activities
- Experience and knowledge in the preparation of major regulatory submissions and supportive documents
- Having knowledge of FDA eCTD submission standards for US Applications
- Experience using change control systems, ideally Track-Wise
- Able to operate computer/office machines
- Lift and/or move up to 20 pounds
- Travel Estimate Up to 20%
- Location: Princeton, New Jersey
- Ability to work cross-functionally to attain goals
Desired Qualifications
- Advanced degree in Regulatory Affairs or pharmaceutical science
- Ability to quickly learn different new/updated electronic software applications
- Ability to use Microsoft Office Suite professionally/ Adobe Acrobat Professional
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.