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Kaleo · 2 days ago

Senior Regulatory Affairs Specialist

Virginia, United States

Full-time

Onsite

Senior Level

5+ years exp

Kaléo has secured multiple contracts with the U.S. government for production of new medical countermeasures, and they are seeking a Senior Regulatory Affairs Specialist to manage and execute the overall Regulatory Affairs programs necessary for regulatory approval of their products. This role involves developing regulatory strategies, preparing submissions to regulatory agencies, and collaborating with team members on various regulatory issues.

BiotechnologyHealth CareMedical

Hiring Manager

Kirsten Guild

Responsibilities

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

Qualification

US Regulatory AffairsRegulatory Affairs Certification (RAC)ECTD softwareNDA submission experienceLaboratory experienceQuality experienceMicrosoft Office SuiteAdobe AcrobatCommunication skillsOrganizational skillsFlexibilityAdaptability