AtsenaDurham, North Carolina, United States · Remote OK
$160k–$220k/yr
Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Department: Regulatory Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The Associate Director / Director, …
Skills: Regulatory Strategy, Gene Therapy, Clinical Development, Nonclinical Development, FDA Interactions
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Patient transport, Customer service, Radiographic equipment setup, Sterile technique, Patient care
Durham, North Carolina, United States · On-site
We offer continuous learning via provided CEU reimbursement, career advancement and specialty certification reimbursement. We have cutting-edge technology and updated equipment. Our Company knows the importance of invest…
Skills: Physical Therapy, Patient Transfer, Clinical Supervision, Patient Care, HIPAA Compliance
Durham, North Carolina, United States · On-site
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Skills: Occupational Therapy, Patient Transfer, Clinical Experience, Patient Care, Compliance Monitoring
Durham, North Carolina, United States · On-site
Description About the Company: CORMETECH, Inc. was founded in 1989 and provides environmental engineering solutions and services to the North American and world's power, marine, industrial-process, refinery, and petroche…
Skills: Project Engineering, Catalyst Management, Design Review, Technical Consulting, Python
Durham, North Carolina, United States · On-site
$13/hr–$16/hr
Benefits: Health insurance Opportunity for advancement Paid time off Training & development Vision insurance Dental insurance Employee discounts Tuition assistance Crawford's Genuine is seeking a professional and friendl…
Skills: Customer Service, Communication Skills, Multitasking, Reservation Management, Time Management
Durham, North Carolina, United States · On-site
Description As a Evening Maintenance Technician, you are responsible for the inspection, repairs, and maintenance of a variety of hotel systems and equipment. Our Maintenance Technicians are thorough professionals with a…
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Durham, North Carolina, United States · On-site
Leasing Consultant Pay range: Hourly + commission At Pegasus, we understand how valuable you are and we want to offer you a career, not a job. If our employees are happy, our owners are happy! We are growing and need YOU…
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Durham, North Carolina, United States · On-site
At Corvias, you’ll join a team wholeheartedly invested in their work. In return, we offer support intended to strengthen your professional, financial, emotional, and physical wellbeing. Your wellbeing is not just a prior…
Skills: Cleaning, Sanitization, Waste Disposal, Inventory Management, Customer Service
Durham, North Carolina, United States · Remote OK
$89k–$114k/yr
The Classification and Compensation Manager is responsible for managing the classification and compensation functions for the organization. The Classification and Compensation Manager plans, develops, and implements new …
Skills: Classification and compensation, Salary surveys, Job analysis, FLSA classification, Data analysis
Durham, North Carolina, United States · On-site
$15/hr–$16/hr
We offer Daily pay! Access up to 50% of your earned wages after every shift. The SpringHill Suites by Marriott Raleigh-Durham Airport/RTP is currently hiring for full-time Housekeeping Attendants. The hours for these pos…
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Durham, North Carolina, United States · On-site
$67k–$73k/yr
At GFiber, we believe that great internet has the power to drive innovation, strengthen communities, enable the impossible, and do all the everyday things that make all of our world go round. And the job of creating bett…
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Durham, North Carolina, United States · On-site
Due to remarkable growth, Johnson Lexus of Durham the exciting opportunity to expand our team with an additional Full-Time Automotive Service Valet! To help keep up with the increasing consumer demands in a fast-paced en…
Skills: Customer Service, Multi-tasking, Verbal Communication, Time Management, Teamwork
Durham, North Carolina, United States · On-site
Hotel Name: Millennium Hotel Durham Location: Onsite – Durham, NC Join the Team at Millennium Durham At Millennium Durham, we believe great hospitality is more than a service—it’s how we make people feel. Every interacti…
Skills: Customer Service, Hospitality Management, Interpersonal Communication, Problem Solving, Attention To Detail
Durham, North Carolina, United States · On-site
This Opportunity WSP’s Engineered Construction team is growing, and we have opportunities for Construction Materials Testing Technicians in Durham, NC to perform field inspections and observations for commercial, industr…
Skills: Soil Density Testing, Concrete Sampling, Field Inspection, ASTM Standards, Nuclear Gauge Testing
Durham, North Carolina, United States · On-site
ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaning…
Skills: Quality Inspection, Raw Material Receiving, Gauging, Instrument Inspection, Data Analysis
Durham, North Carolina, United States · Hybrid
ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaning…
Skills: Accounts Payable, Accounts Receivable, Financial Record Keeping, KPI Monitoring, Month-end Close
Durham, North Carolina, United States · Hybrid
JOB PURPOSE: Provide excellent customer service to partners when working with users on site at remote locations and through phone support. Strong troubleshooting and analytical skills required to resolve complex issues. …
Skills: Troubleshooting, Windows Server, Citrix Management, Active Directory, Network Basics
Durham, North Carolina, United States · On-site
LC Industries Production Supervisor ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of pe…
Skills: Production Supervision, Workflow Expediting, Scheduling, Inventory Control, Microsoft Excel
Durham, North Carolina, United States · Hybrid
$107k–$178k/yr
Req ID: 374063 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are…
Skills: Kotlin, Android SDK, Android Studio, Jetpack Components, REST API Integration
Atsena
Durham, North Carolina, United States • Remote OK
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Lead global regulatory strategy and execution for gene therapy programs from early research through commercialization. Serve as the primary regulatory liaison for internal teams and global health authorities like the FDA and EMA.
Requires a PhD, PharmD, MD, or MS in life sciences with 7 to 15+ years of regulatory affairs experience in biotech or pharma. Expertise in biologics, gene therapy platforms, and global regulatory filings is essential.
Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Department: Regulatory
Reports To: VP of Regulatory
Location: Remote or Onsite
Position Summary:
The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This individual will be responsible for developing nonclinical and clinical regulatory strategies, supporting regulatory submissions, and serving as the regulatory liaison to internal nonclinical and clinical teams.
This role requires strong experience in regulatory strategy for biologics or gene therapies and the ability to work cross-functionally with clinical development, clinical operations, nonclinical, quality and program leadership. This individual will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.
Key Responsibilities:
Regulatory Strategy Development
Regulatory Submissions
Health Authority Interactions
Cross-Functional Collaboration
Regulatory Intelligence & Compliance
Qualifications:
Education
Preferred Qualifications
Associate Director Experience
Director Experience
Knowledge & Skills
Key Competencies
