Regulatory Strategy Associate

Premier Research

Regulatory Strategy Associate preparing IND Modules and supporting submissions for biotech and pharma companies. Interfacing with regulatory affairs leadership and international affiliates.

Posted 6/6/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $71,000 per yearWebsite

About the role

Key responsibilities & impact

Independently prepare IND Modules for routine submissions
Support regulatory affairs leadership in preparation of complex submissions
Perform thorough independent background research through all pertinent search engines
Ensure that documents appropriately evaluate and present data and methodology
Navigate and obtain information for projects from all available resources
Produce timely, scientifically accurate data summaries
Construct documents in a manner consistent with applicable regulations and guidance
Serve as Regulatory representative in department discussions
Interface with international affiliates on regional regulatory strategy

Requirements

What you’ll need

Master’s degree or international equivalent in a science or health related field; PhD or PharmD preferred
3+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry
Strong scientific verbal and writing skills
Excellent organizational, writing, communication and time management skills
Ability to communicate and interact effectively within the department, across departments and on project team(s)

Benefits

Comp & perks

health insurance
retirement plans
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

IND Modules preparationregulatory submissionsbackground researchdata evaluationscientific data summariesdocument constructionregulatory compliance

Soft Skills

scientific verbal skillswriting skillsorganizational skillscommunication skillstime management skillsinterpersonal skills

Certifications

Master’s degreePhDPharmD