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Kaleo · 3 days ago

Senior Specialist, Regulatory Affairs

Richmond, VA

Full-time

Onsite

Senior Level

5+ years exp

Kaléo is a company that has secured multiple contracts with the U.S. government for the production of new medical countermeasures. The Senior Regulatory Affairs Specialist will manage and execute the overall Regulatory Affairs programs necessary to achieve and maintain regulatory approval for Kaleo's products, working across a spectrum of regulatory issues for both drug and device regulations.

BiotechnologyHealth CareMedical

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 submissionsCombination productsMicrosoft Office SuiteAdobe AcrobatCommunication skillsOrganizational skillsAttention to detail