Regulatory Affairs Specialist II

Horizon Med Innovation Inc

Posted on : 09-05-2025

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1 Vacancy

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Job Location

Laguna Hills, CA - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 09-05-2025

Job Description

Assess the acceptability of development quality preclinical and clinical documentation for submission filing. Compile prepare review and submit regulatory submissions to authoritiesIdentify key areas of regulatory risk and probabilities of mitigation strategies and ensures implementation and follow robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectivesSupport pre and post approval clinical strategy and submission cross functional alignment with issues that could have Regulatory strategic partnerships to further departmental and organizational and approve preclinical clinical and manufacturing changes for compliance with applicable regulations and evaluates appropriate regulatory filing strategies. Anticipate regulatory obstacles and emerging issues including new and proposed regulations throughout the product lifecycle and develop solutions with other members of regulatory and crossfunctional implement and manage regulatory SOPs processes and systems as evaluate and interpret applicable regulatory requirement to assure compliance with internal policies and external requirements and and manage complex projects and prioritizes Requirements:Masters in Public Health or Health : $74464 yearInterested candidates: please send your resume and cover letter to:

Employment Type

Full Time

Company Industry

Biotechnology Research / Pharmaceutical Manufacturing

Key Skills

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About Company

Horizon Med Innovation Inc

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Regulatory Affairs Specialist II

Horizon Med Innovation Inc

Job Description

Employment Type

Company Industry

Key Skills

About Company

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