Durham County, North Carolina, United States · Hybrid
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: CMC Regulatory Affairs, Labeling, Module 3, eCTD, Regulatory Submissions
Christiansburg, Virginia, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Quality Assurance, Quality Control, Microbiology, Environmental Monitoring, CAPA Management
Jacksonville, Florida, United States · Hybrid
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Equipment Validation, GMP Compliance, Validation Protocol Development, Root Cause Analysis, Change Control Management
Durham County, North Carolina, United States · Remote OK
$101k–$132k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: SQL, Power BI, Microsoft Fabric, Data Mining, Data Cleansing
Colorado, United States · Remote OK
$150k–$185k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Market Access, Field Reimbursement, Patient Access, Provider Engagement, Specialty Pharmacy Management
Ohio, United States · Remote OK
$130k–$180k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Pharmaceutical Sales, Clinical Acumen, Territory Management, Relationship Building, Scientific Communication
Silver Spring, Maryland, United States · Remote OK
$158k–$210k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Contract Negotiation, Payer Access, Reimbursement Expertise, Stakeholder Engagement, Business Case Development
Jacksonville, Florida, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Ex-Vivo Lung Perfusion, Sterile Technique, Surgical Cannulation, Critical Care, Ventilator Management
Manchester, New Hampshire, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: 3D Bioprinting, Tissue Engineering, Biomaterials, Hydrogel Scaffolds, Peptide Conjugation
Cambridge, Massachusetts, United States · On-site
$79k–$105k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: In Vivo Pharmacology, Rodent Handling, Flow Cytometry, qPCR, ELISA
Durham County, North Carolina, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Pharmaceutical Packaging, GMP Documentation, HMI Control Systems, Equipment Setup, Kitting Operations
Durham County, North Carolina, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Electronic Batch Records, MES Administration, Project Management, GxP Compliance, FDA CFR Part 11
Durham County, North Carolina, United States · Hybrid
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Product Management, Marketing Strategy, Cross-Functional Collaboration, Project Management, Market Research
Silver Spring, Maryland, United States · Hybrid
$88k–$135k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: GMP Auditing, GDP Auditing, Quality Management Systems, Vendor Management, Regulatory Compliance
Durham County, North Carolina, United States · Hybrid
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Patient Marketing, Product Management, Strategic Planning, Cross-functional Leadership, Market Research
Silver Spring, Maryland, United States · Hybrid
$93k–$125k/yr
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Cash Positioning, Payment Processing, Treasury Reporting, SAP, Kyriba
Silver Spring, Maryland, United States · Hybrid
$91k–$125k/yr
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: IT Security, Risk Management, Compliance, Vulnerability Management, Risk Assessment
Durham County, North Carolina, United States · On-site
The Job Details are as follows: GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI) Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public bene…
Skills: Preventative Maintenance, Troubleshooting, Pneumatic Systems, Electronic Control Systems, Hydraulic Control Systems
Silver Spring, Maryland, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Cybersecurity Strategy, Risk Management, Compliance, NIST CSF, NIST AI RMF
Durham County, North Carolina, United States · On-site
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purp…
Skills: Cell Culture, In Vitro Assays, Flow Cytometry, Immunostaining, Fluorescence Microscopy
Durham County, North Carolina, United States • Hybrid
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The role involves leading the preparation and review of regulatory CMC and labeling documents for US, EU, and other global markets. It also requires collaborating with manufacturing and quality groups to implement regulatory strategies and mentoring junior staff.
Candidates must have a science degree and significant direct experience in regulatory affairs CMC, ranging from 2 to 8+ years depending on the degree level. Proficiency with electronic publishing tools like eCTDs and strong organizational skills are required.
California, US residents click here.
Who We Are
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are
Do you have extensive, highly technical CMC knowledge? If you're passionate about getting novel treatments into the hands of those who need them – and you know your way around Module 3 like the back of your hand – you might be exactly who we’re looking for.
The Regulatory Affairs Manager will manage and lead the preparation, compilation, and review of regulatory submissions and related CMC and labeling documents pertaining to US, EU, and ROW for assigned projects. This role will collaborate with the manager, project teams, and functional area representatives to devise and implement sound regulatory CMC and labeling strategies.
Minimum Requirements
Preferred Qualifications
Job Location
This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs. This position may travel up to 10%. Relocation assistance may be available for non-local candidates.
At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
Enabling Inspiration
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions. Our purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. We are bold and unconventional. We have fun, we do good. We are also the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.
Offices: 1000 Spring Street, Silver Spring, Maryland 20910, US · 55 T.W. Alexander Drive, P.O. Box 14186, Research Triangle Park, North Carolina 27709, US
Enabling Inspiration
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions. Our purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. We are bold and unconventional. We have fun, we do good. We are also the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation.
Offices: 1000 Spring Street, Silver Spring, Maryland 20910, US · 55 T.W. Alexander Drive, P.O. Box 14186, Research Triangle Park, North Carolina 27709, US
