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Vivid Resourcing · 6 hours ago

Senior Manager/Associate Director, Regulatory Affairs

Florida, United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$150K/yr - $180K/yr

5+ years exp

Vivid Resourcing is currently seeking a Regulatory Affairs expert for their US division. The Senior Manager/Associate Director will be responsible for preparing regulatory submissions, leading interactions with regulatory authorities, and ensuring compliance with regulatory standards.

EmploymentRecruitingStaffing Agency

Growth Opportunities

Responsibilities

Help with regulatory requirements and prepare regulatory submission for all new/modified combination products, drugs, and medical devices. These submissions can include but not be limited to IND’s, BLA’s, meeting packages and expediated programs. These submissions can include but not be limited to 510 (k)s, IDEs, and PMAs as well as INDs and BLAs

Ensure timely preparation of high-quality regulatory documentation and dossiers

Lead interactions with regulatory authorities, including setting meeting objectives, preparing briefing materials, coordinating internal rehearsals, and managing risk-mitigation plans

Collaborate closely with cross-functional teams to integrate regulatory considerations into program plans and ensure alignment with overall development timelines and objectives

Present and defend regulatory strategies in project team meetings and with external partners

Work with internal functions to ensure compliance with regulatory standards and support audit/inspection readiness

Maintain up-to-date knowledge of relevant regulatory guidelines, global requirements, and the evolving competitive landscape

Provide support across additional regulatory or program activities as needed

Qualification

Regulatory Affairs expertiseOncology experienceRegulatory document authoringMicrosoft Office SuiteDatabase compliance softwareCommunication skillsProject management

Required

Bachelor's Degree/ Master's degree in Life Sciences, Engineering or related field

5+ years in a regulatory capacity with Oncology experience

High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them

Ability in authoring regulatory documents such as M1, M2 of an IND, IND amendments, response to regulatory agency's IR, expediated program applications

Ability to inform and educate managers and department heads on regulations and policies that require compliance

Ability to translate regulatory requirements into practical, workable plans

Proficient with Microsoft Office Suite or similar software

Proficient with applicable database and compliance software

Must be able to juggle multiple and competing priorities