Senior Specialist, Regulatory Affairs
Kaleo Software
full-time
Posted on:
Location Type: Remote
Location: Virginia • United States
Visit company websiteExplore more
Job Level
About the role
- Develops and implements regulatory strategies to facilitate the progress of programs in all phases of development.
- Prepare annual reports, supplements, amendments, and change notifications to regulatory agencies and ensure periodic reports are submitted to regulatory dossiers.
- Participate with team members in drafting and submitting dossiers in different regions around the world, including Chemistry, Manufacturing, and Controls (CMC); nonclinical; human factors; clinical; and pharmacovigilance activities.
- Assist in drafting and reviewing product labeling.
- Review clinical and non-clinical study protocols and other documentation, and assess clinical study related changes to determine regulatory impact.
- Review human factors study protocols and other human factors documentation.
- Support regulatory audits, as required.
- Assist in developing and maintaining Regulatory Affairs department procedures.
Requirements
- A bachelor’s degree in a scientific discipline or equivalent combination of education and experience.
- At least 5 years of laboratory, regulatory, or quality experience in the pharmaceutical, biotechnology, or medical device industries.
- Specialist knowledge in US Regulatory Affairs and industry best practices
- Proficiency with Electronic Common Technical Document (eCTD) software.
- Proficiency with Microsoft Office Suite.
- Proficiency with Adobe Acrobat.
- Experience submitting to regulatory agencies, including NDAs.
- Experience with combination products (drug / device) preferred.
- Regulatory Affairs Certification (RAC) strongly preferred.
Benefits
- Application required for consideration
- Contact talentacquisition@kaleo.com with any additional questions.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory submissionsproduct labelingclinical study protocolshuman factors documentationregulatory auditseCTD softwareMicrosoft Office SuiteAdobe Acrobatcombination products
Certifications
Regulatory Affairs Certification (RAC)