Senior Specialist, Regulatory Affairs
Kaleo Software
full-time
Posted on:
Location Type: Remote
Location: Virginia • United States
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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
regulatory strategiesregulatory submissionsproduct labelingclinical study protocolshuman factors documentationregulatory auditseCTD softwareMicrosoft Office SuiteAdobe Acrobatcombination products
Certifications
Regulatory Affairs Certification (RAC)