Regulatory Affairs Jobs in Charleston
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Search Results - Regulatory Affairs Jobs in Charleston
Insmed-Charleston
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
Structure Therapeutics-Charleston
Regulatory Affairs, Biostatistics, and other teams to ensure submissions meet quality and regulatory standards. The role emphasizes FDA/EMA/ICH compliance, robust document management, and cross-functional leadership in a remote-first setup.
This is a chance...
Medline-Charleston
Overview
In this remote leadership role you drive global regulatory strategies to bring new medical device products to market and support existing products. You will negotiate with regulators, guide cross-functional teams, and inform product...
Medtronic-Charleston
Medical safety and risk management
• Post-market surveillance
• Regulatory affairs knowledge (FDA, EU MDR)...
Medtronic-Charleston
and lifecycle decision-making
• Respond to safety inquiries from internal stakeholders, healthcare professionals, and regulatory agencies
• Collaborate with Medical Safety, Clinical, Regulatory Affairs, Risk Management, and Quality teams on emerging safety...
Danaher Corporation-Charleston
8+ years of progressive experience in quality, audits, regulatory affairs, or related areas within diagnostics, biopharma, medical devices, CROs, or similar regulated industries
• Working knowledge of regulated quality systems and audit practices...
US Pharmacopeia-Charleston
advisor to pharmaceutical developers and manufacturers
• Create User Forums, Quality Hours, Workshops and Webinars with Scientific Affairs, Regulatory Affairs to showcase USP value
• Partner with regional distributors for aligned, resource-shared, joint...
Premier Research-Charleston
in pharma/CRO/biotech/consulting
• At least 7 years in a regulatory affairs management role
• Experience preparing regulatory submissions in US and/or Europe
• Experience with supervisory and financial management in regulatory affairs
• Proven track record...
State of New York, USA-Charleston
portfolio
• Assist General Counsel with legislation, regulatory affairs, and drafting correspondence to the Governor
• Advise on grant administration, FOIL, insurance, and other corporate matters
• Provide guidance on investment, custodial, and transfer...
Acrisure-Charleston
to Regulatory Affairs, Risk, Compliance, Sourcing, HR, etc., with capabilities like template filling, data extraction, contract analysis, drafting, and jurisdictional alignment
• Facilitate ideation sessions and lead technical build-out after teams are trained...
Stryker-Charleston
Overview
As Lead Analyst in Clinical Data Sciences, you will shape evidence strategy and manage evidence workflows across Medical Affairs, Clinical Research, Regulatory, and Market Access. You will translate clinical and regulatory questions...
Takeda-Charleston
regulatory, and medical affairs teams.
Compensation / Benefits
• remote work up to 100%
• medical, dental, and vision insurance
• 401(k)
• paid time off
• sick leave
• incentive compensation programs
Responsibilities
• Lead global safety strategy...
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