Regulatory Affairs Jobs in Durham
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Search Results - Regulatory Affairs Jobs in Durham
Wake Research-Durham
and networks with internal and external medical professional and local opinion leaders
Work closely with colleagues in other functions including, Regulatory Affairs, Clinical Operations and Patient Engagement
Lead and provide an oversight to a team...
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Kedrion Biopharma Inc. KEDPLASMA LLC.-Durham
objectives.
• In-depth knowledge of US pharmaceutical market which includes experience working with regulatory affairs, medical affairs, finance, and promotional review teams
• Ability to succeed in an entrepreneurial / high rate of change organization...
Lifelancer-Durham
quality expectations for the vendors in clinical trials.
Serve as the CQA SME for cross-functional team meetings with Clinical Development (Clinical Operations, Nonclinical, Data Management, Biostatistics, Pharmacovigilance, Legal and Regulatory Affairs...
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SpringWorks Therapeutics-Durham
IBs, ICFs, and other regulatory documents/submissions.
• Responsible to develop and maintain RSI, CCSI/safety sections of CCDS and local labels
• Prepares dRMPs/RMPs and coordinates with input from stakeholder departments such as Medical Affairs...
Lifelancer-Raleigh, 21 mi from Durham
Job Title: Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
Job Location: Raleigh, NC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
At Johnson & Johnson, we believe health is everything. Our...
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PharmEng Technology Americas-Holly Springs (NC), 24 mi from Durham
Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best...
Lifelancer-Raleigh, 21 mi from Durham
Job Title: Mgr, Regulatory Affairs Pharma - HealthCanada
Job Location: Raleigh, NC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
PURPOSE AND SCOPE:
Ensure overall (other than auditing...
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The Clearing House-Raleigh, 21 mi from Durham
will assist the VP CoS / Regulatory Affairs with the execution of applicable regulatory follow up requests, notes from regulatory meetings, execution of regulatory exams and reviews along with the solicitation and compilation of various committee material...
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Katalyst Healthcares & Life Sciences-Raleigh, 21 mi from Durham
Biological Science, Biotechnology.
Scientific secondary-school diploma with at least 7 years of experience within International Regulatory Affairs.
At least 5 years of experience in Regulatory Affairs.
General knowledge of the drug development process...
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Katalyst Healthcares & Life Sciences-Cary, 17 mi from Durham
Responsibilities:
Regulatory Submission: Prepare and submit documents to regulatory authorities, including Investigational New Drug (IND) applications and Abbreviated New Drug Applications (ANDA).
Compliance Monitoring: Ensure that clinical trials...
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