Regulatory Affairs Jobs in Madison
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IlluminaMadison
Responsibilities
• Represent the regulatory affairs function on cross-functional projects
• Create regulatory strategies for domestic and international markets
• Develop and execute regulatory plans for complex products and maintain approvals
• Prepare information...
Madisonpromega.com
skills, learn from experienced mentors, and contribute to meaningful projects that support Promega's mission and daily operations.
JOB OBJECTIVE: The QARA Intern will support the Quality Assurance and Regulatory Affairs teams by assisting in various...
InsmedMadison
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...
Madisonpromega.com
3. Reviews and approves labels, technical bulletins, technical manuals, and certificates of analysis.
4. Approves study designs and change plans for shelf life and product changes, in partnership with Manufacturing, Marketing, Regulatory Affairs...
InsmedMadison
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...
MedlineMadison
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...
MedtronicMadison
Medical safety and risk management
• Post-market surveillance
• Regulatory affairs knowledge (FDA, EU MDR)...
IlluminaMadison
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
IlluminaMadison
Management, Regulatory Affairs, Market Access, Legal, Compliance and Commercial teams
• Contribute to publication planning and external scientific communications
• Maintain independence and compliance with regulations governing medical affairs...
MedtronicMadison
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...
US PharmacopeiaMadison
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...
AcrisureMadison
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...
Merck Sharp & Dohme (MSD)Madison
finance, regulatory affairs, pharmacovigilance, and HQ
• Support team knowledge sharing and buddying within the country operations
Key requirements
• Bachelor's Degree or higher
• 3+ years of experience in negotiating contracts or budgets
• Juris Doctor...
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