Regulatory Affairs Specialist
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Job Description
The Regulatory Affairs Specialist supports regulatory strategy, submissions, and compliance activities to ensure products and clinical trials meet applicable regulatory requirements. This role acts as a liaison between regulatory agencies and internal teams to support timely approvals and ongoing compliance.
Job Responsibilities
Key Job Responsibilities
Prepare, submit, and maintain regulatory submissions (IND, NDA, IDE, CTA, amendments)
Ensure compliance with FDA, EMA, and global regulatory requirements
Support regulatory strategy development for clinical trials and product development
Maintain regulatory documentation and submission tracking
Communicate with regulatory authorities as needed
Support audits, inspections, and responses to regulatory inquiries
Collaborate with clinical, quality, and development teams
Skills + Experience
Required Skills & Competencies
Strong understanding of FDA, EMA, and global regulatory frameworks
Excellent technical writing and documentation skills
Strong attention to detail and organizational abilities
Ability to interpret regulations and apply them to projects
Required Experience & Qualifications
Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field
3+ years of regulatory affairs experience (clinical or product-focused)
Experience with regulatory submissions and agency interactions
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JOB CATEGORY
Life Science
LOCATION
Remote Position
JOB TYPE
Full Time
EXPERIENCE LEVEL
Mid Level
SALARY
$85k - $120k
REFERENCE NUMBER
#222639822
About Us
At Renclave, our approach is built on clarity, expertise, and long-term relationships. We understand that career moves and hiring decisions are significant, which is why we focus on delivering a disciplined, transparent experience from start to finish.
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When you work with Renclave, you can expect:​
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Industry-informed guidance from recruiters who understand regulated and technical environments
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Confidentiality and discretion throughout the recruitment process
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Opportunities aligned with your experience, goals, and market value
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Clear communication at every stage—no uncertainty or unnecessary delays
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Professional advocacy, whether you are a candidate or a hiring partner
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Our goal is not to place quickly—it is to place correctly.