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Senior Regulatory Affairs Specialist
Senior Regulatory Affairs SpecialistVirtualVocations • Houston, Texas, United States
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

VirtualVocations • Houston, Texas, United States
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

A company is looking for a Senior Specialist, Regulatory Affairs.

Key Responsibilities

Develop and implement regulatory strategies for programs in all development phases

Prepare and submit reports, amendments, and change notifications to regulatory agencies

Assist in drafting and reviewing product labeling and regulatory documentation

Required Qualifications

Bachelor's degree in a scientific discipline or equivalent experience

At least 5 years of experience in laboratory, regulatory, or quality roles in relevant industries

Specialist knowledge in US Regulatory Affairs and industry best practices

Proficiency with eCTD software, Microsoft Office Suite, and Adobe Acrobat

Experience with NDA submissions and combination products preferred; Regulatory Affairs Certification (RAC) strongly preferred

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Regulatory Specialist • Houston, Texas, United States

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