78 Results for

Regulatory Specialist Jobs in Durham, NC

Jobs

New!

Raleigh, NC6 days ago

The Pro CRE Loan Specialist position is a specialized position responsible for reviewing and understanding the Commercial Real Estate Loan approval/request, providing thorough, objective analysis of the Loan closing, construction documentation and funding requirements in the RE loan documents, and all supporting documentation required for closing, and confirming that the loan documents provide that the loan is being closed as required by the approval. Headquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services.

New!

Chapel Hill, NC1 day ago

$31.04–$44.62 Per Hour

Provides technical expertise in specific laboratory discipline or program specialty, monitor and direct the workload and provides consultative and diagnostic results to clinicians. Requires flexibility in schedules as procedures and/or training schedules may require early or late starts.

New!

Raleigh, NC1 day ago

$31.04–$44.62 Per Hour

May provide input into budgetary process by identifying capital equipment needs and anticipating laboratory or program needs. Must possess a strong working knowledge of both manual and automated hematology processes, including manual cell identification.

Research Triangle Park, NC11 days ago

$0–$33 Per Hour

Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Raleigh, NC20 days ago

$33.04–$47.50 Per Hour

Operates multichannel physiologic monitor to measure and record functions of cardiovascular and pulmonary systems of patient during cardiac catherization. Learn more about the incentive program here: https://jobs.unchealthcare.org/pages/imaging-commitment-incentive-program.

Raleigh, NC11 days ago

High school diploma or equivalent; Ten years of experience directly related to elevator and chairlift installation and repair; Experience in servicing elevators and chairlifts, including software updates; Experience with multiple elevator manufacturers; An equivalent combination of education and relevant experience sufficient to successfully perform the essential duties of the job. POSITION PURPOSE: Performs complex level work in repairing, maintaining, and programming elevators and chairlifts located within a Wake County Public School System (WCPSS) facilities.

Haw River, NC14 days ago

Manages several EHS projects/programs as assigned which may include the following, but is not limited to: • Operations review, continual improvement, and Cross Functional Team • Safety Near Miss / Unsafe Condition and/or Peer Observation Program review, tracking, and data analysis • WMU Administration (curriculum, training groups, assignments, trouble-shooting) and related materials distribution and updates • Safety and/or Environmental Recognition Programs • Rules Book Implementation and Updates • Safety or Environmental special focus or training events • Safety or Environmental performance summaries and communications. Administers or uses certain databases and software (e.g., AIMS, CYCLE, ACE, Dakota Tracer, Excel, ARI Insights, DISA, CA DMV, SharePoint, InfoPath, etc.) to track people, assets, program conformance, regulatory compliance, and similar.

Stem, NC27 days ago

Posting Title: Family Nurse Practitioner / Physician Assistant - $5k Sign-On Bonus Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.

Creedmoor, NC22 days ago

Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.

New!

Henderson, NC6 days ago

New!

Henderson, NC6 days ago

Creedmoor, NC22 days ago

New!

Raleigh, NC2 days ago

As a member of the site Quality Leadership Team, the Director partners cross-functionally with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence. The Director, Quality Control provides strategic and operational leadership for all Quality Control (QC) activities supporting drug substance (DS) and dug product (DP) manufacturing at the site.

Raleigh, NC20 days ago

Full-time

Peregrine Team is seeking a Regulatory Affairs Specialist to support global regulatory submissions and ensure compliance across pharmaceutical products. This role will work closely with cross-functional teams to support product approvals and lifecycle management.

Research Triangle Park, NC27 days ago

This role is ideal for candidates with hands-on Safety Data Sheet (SDS) authoring experience and familiarity with regulatory frameworks such as GHS and/or FIFRA.This is a fully onsite position supporting a collaborative team focused on product compliance, data accuracy, and regulatory alignment. OverviewWe are seeking an experienced SDS Specialist / Product Regulatory Specialist to support regulatory compliance and safety documentation in a highly regulated environment.

Durham, NC10 days ago

Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world.

Durham, NC30+ days ago

Remote

The Manager, Regulatory Affairs drives key regulatory activities, working seamlessly across functions to translate scientific, clinical, and technical insights into high-quality regulatory submissions while supporting regulatory strategy across the organization. Diverse experience authoring, reviewing, and editing documents for regulatory submission such as INDs, IMPD, CTAs, BLAs, and MAAs, as well as supporting related health authority interactions (previous experience with CBER a plus).

Raleigh, NC30+ days ago

Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.

Research Triangle Park, NC30+ days ago

The Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

Raleigh, NC30+ days ago

Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

Raleigh, NC30+ days ago

As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Raleigh, NC30+ days ago

$165,000–$225,000 Per Year

12+ years of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or a related area of study. We are focused on the research and development of transplantable kidneys ( mirokidney® ), livers ( miroliver® ), and a bioengineered external liver assist device for acute liver failure ( miroliver_ELAP_® ), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

Raleigh, NC30+ days ago

$169,344–$264,600 Per Year

The responsibilities of the position include, but are not limited to, the following: + Demonstrate a high degree of knowledge about the political, economic, and social factors affecting public policy decision making; how engagement with government officials can lead to the enactment of new or the modification of existing regulations; implement policies and take other governmental actions that are favorable to Chemours’ business growth, corporate well-being, and the industry sectors in which the company operates. The successful candidate will join Chemours’ Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs.

Cary, NC30+ days ago

Remote

Oversee HA interactions and project leadership: Lead/participate in Health Authority communications (e.g., meetings, teleconferences); review/author regulatory content for submissions; contribute expertise on drug/device development as a Leadership team member reporting to Senior Leadership, serving on project teams in roles like Subject Matter Expert or Project Lead. As the VP Regulatory Affairs, you will: Lead regulatory activities and team management: Assist clients with regulatory aspects of drug, biologic, or medical device products; provide counsel, manage the regulatory team (potentially with direct reports), and translate requirements into practical plans while ensuring timely, scientifically valid submissions.

Durham, NC30+ days ago

Temporary

Support with Regulatory Submission and other Regulatory Operations related activities Minimum Requirements: Currently enrolled in a Masters of Pharmaceutical Sciences Regulatory Sciences Program with at least one semester of coursework completed Strong understanding of drug development processes and regulatory frameworks Basic understanding of Health and Human Services (HHS), and Food and Drug Administration (FDA) Excellent English written and verbal communication skills Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) Strong attention to detail and organizational skills Ability to work both independently and collaboratively in a team environment Demonstrated interest in cell and gene therapy or biologics regulation Preferred Education, Experience and Skills: Previous internship or work experience in pharmaceutical, biotech, or regulatory environments Knowledge of FDA and ICH guidelines relevant to biologics and advanced therapies Understanding of GMP, GCP, GLP, and quality systems Experience with regulatory information management systems Apply regulatory science principles learned in coursework to evaluate guidance documents, regulatory precedents, and emerging policies relevant to advanced therapy medicinal products (ATMPs).

Morrisville, North Carolina30+ days ago

Job Summary: The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed.

Raleigh, NC30+ days ago

If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

Morrisville, North Carolina30+ days ago

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures.

Raleigh, North Carolina8 days ago

Our nationwide reach is powered by a family of trusted brands that include: Hospice care: Gentiva Hospice, Emerald Coast Hospice Care, Heartland Hospice, Hospice Plus, New Century Hospice, Regency SouthernCare, SouthernCare Hospice Services, SouthernCare New Beacon. Our place is by the side of those who need us – from helping people recover from illness, injury, or surgery in the comfort of their homes to guiding patients and their families through the physical, emotional, and spiritual effects of a serious illness or terminal diagnosis.

Raleigh, NC30+ days ago

$35.25–$54.39 Per Hour

The Clinical Documentation Specialist ensures clinical documentation is accurate, consistent, compliant, and specific through the performance of reviews and initiation of queries to providers to achieve appropriate ICD-10 code and DRG (Diagnosis Related Groups) assignment for each patient. Acute care includes medical/surgical or similar experience integrating knowledge of pathophysiology and acute care and disease management, physical assessment, clinical evaluation and monitoring with best practice treatment modalities for inpatient hospital populations (excluding rehab, psych).

Morrisville, North Carolina30+ days ago

Morrisville, North Carolina12 days ago

Research Triangle Park, NC29 days ago

The Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Durham, NC30+ days ago

S/he will ensure that all employees, contractors, and relevant third parties are appropriately trained in accordance with regulatory requirements and will partner with functional leaders to design, deliver, and track effective training programs. The Training Specialist/Manager, Quality will help advance this mission by coordinating, maintaining, and enhancing the company's GxP training program to support both clinical development and commercial operations.

Raleigh, NC30+ days ago

Remote

$65,000–$75,000 Per Year

As a Facets ID Card Configuration Specialist , you will make an impact by ensuring accurate configuration and validation of ID cards within Facets for targeted groups. Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.

Raleigh, NC30+ days ago

$10–$15 Per Hour

We don’t simply say our employees are our most valuable resource – we live it with emphasis on providing outstanding benefits related to your time (our PTO and paid Holidays are legit!); health and dental insurance; wages (some sources show we pay in the top 10-15% of the market); and much, much more. By joining our team at Proesis Bio Raleigh, you will not only be embarking on an exciting professional journey, but you'll also have the chance to make a real, tangible difference in the lives of people across our global communities, each and every day.

Knightdale, North Carolina21 days ago

$19.08–$21.84 Per Hour

Holly Springs, NC30+ days ago

Prior hands-on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

Raleigh, North Carolina30+ days ago

$20–$24 Per Hour

Collaborate with internal teams to process contracts and provide solution‑focused technical assistance and training related to contracting, budgeting, financial compliance, and fiscal monitoring, ensuring alignment with organizational policies and applicable regulatory guidelines. Support the design, development, and delivery of high‑quality training materials, tools, and resources to improve accessibility, engagement, and effectiveness of training and technical assistance on financial and contracting topics.

Raleigh, NC30+ days ago

Share this job with a friend (https://careers-kimley-horn.icims.com/jobs/20418/human-resources-compliance-specialist/job?mode=apply&apply=yes&in_iframe=1&hashed=-1834442239). We take pride in how our employee retention, robust benefits package, and company values have led to Kimley-Horn’s placement on the Fortune “100 Best Companies to Work” list for 18 years!

New!

Raleigh, NC5 days ago

The Virtual Sales Specialist implements the client's marketing plan by delivering proficient sales presentations to a defined list of current and prospective customers. Execute client-directed outbound calls, emails, and virtual strategic interactions with assigned targets and prospective customers to deliver effective sales presentations.

Cary, NC30+ days ago

$18–$19 Per Hour

We believe that bringing together people with diverse thoughts, backgrounds, talents, and experiences at all levels of our organization, including the executive team, enables us to proactively and creatively achieve our mission to enable opportunities for hard-working American families. An Approach that is positive and Professional - Consistently demonstrate an approach of active listening and understand that your participation and support are integral to the success of Avanath, ensuring that each resident and staff member feels seen, heard, and valued as you and the staff work to resolve challenges.

Durham, North Carolina20 days ago

We’ve already built an industry-leading cloud compliance platform, processing over 54 billion customer API calls and over 6.6 million tax returns a year. As our Workplace Specialist in our Durham office, you will help foster a positive, inclusive, and engaging workplace culture that supports employee connection, productivity, and well-being.

Morrisville, North Carolina21 days ago

Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Holly Springs, NC30+ days ago

High School Diploma or Equivalent with 12 years of applicable industry experience OR• Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 8 years of applicable industry experience OR• Master’s degree with 4 years previous applicable industry experience• Equivalent military experience or training• Experience in drug product manufacturing, sterile processing, or quality assurance. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

Raleigh, NC20 days ago

Full-time

Our trusted community doctors and knowledgeable teams are all focused on helping our patients live their best lives by delivering an exceptional, personalized experience to each of our patients in every interaction. Manage administration of payroll including importing and processing timesheets for all exempt, non-exempt and part-time employees, computation of required and voluntary deductions and preparation and verification of payrolls.

Holly Springs, North Carolina19 days ago

This role works closely with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, project initiatives, and client requests. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

Cary, NC21 days ago

The ideal candidate ensures exceptional customer satisfaction while supporting the Customer Account Associates and Sales Account Managers. They will be responsible for administrative tasks such as processing orders, managing customer accounts, logistical details and assisting with sales documentation.

Chapel Hill, NC30+ days ago

Contractor

Key Responsibilities Program Development & Implementation Establish and implement the facilitys environmental monitoring program Collaborate with third-party vendors to define best practices Develop processes and schedules for ongoing monitoring activities Data Analysis & Reporting Conduct environmental monitoring testing Review, analyze, and trend environmental data Provide regular reports on environmental status and emerging trends Quality & Compliance Ensure adherence to Good Manufacturing Practices (GMP) Investigate environmental excursions and contamination events Identify root causes and implement corrective actions Documentation & Training Create and maintain technical documentation for the EM program Train technicians on: Aseptic techniques Gowning procedures and qualifications Continuous Improvement Work independently to identify risks and improve monitoring processes Develop and implement corrective and preventive actions (CAPA) Required Qualifications Bachelors degree (required) Knowledge of Microsoft Office (Word, Excel, PowerPoint) Understanding of Good Manufacturing Practices (GMP) Preferred Qualifications Minimum 3 years of experience in a GMP environment Experience in environmental monitoring within manufacturing or laboratory settings The position requires collaboration with internal stakeholders and external vendors, along with independent decision-making to identify risks and improve processes.

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Regulatory Specialist Jobs in Durham, NC

Jobs

Commercial Real Estate Loan SpecialistFirst Horizon Bank

Medical Lab Specialist - Quality ManagementUNC Health

Medical Lab Specialist - Rex Core LabUNC Health

Quality Assurance Specialist IIDivIHN Integration Inc

Cardiovascular Specialist - Rex Invasive Heart & VascularUNC Health

Technical Specialist-Elevator TechnicianWake County Public School System

Operational EHS SpecialistWaste Management

Family Nurse Practitioner / Physician Assistant - $5k Sign-On BonusFast Pace Health

Family Nurse Practitioner / Physician Assistant - Flexible SchedulesFast Pace Health

Family Nurse Practitioner / Physician Assistant - Growth OpportunityFast Pace Health

Family Nurse Practitioner / Physician Assistant - New Grad Opportunity with Extensive Training Program!Fast Pace Health

Family Nurse Practitioner / Physician AssistantFast Pace Health

Director, Quality ControlCellectis

Regulatory Affairs SpecialistPeregrine Team

SDS Specialist (Regulatory Compliance)CrossFire Group

EHS Regulatory Compliance SpecialistStefanini, Inc

Manager, Regulatory AffairsPrecision Biosciences

Director, Regulatory Affairs – Clinical StrategyAzurity Pharmaceuticals - US

Associate Director, Regulatory Affairs (CMC)Kriya Therapeutics

Global Head of Regulatory AffairsAzurity Pharmaceuticals - US

Regulatory Affairs Associate/Senior AssociateAzurity Pharmaceuticals - US

Associate Director, Regulatory AffairsUnited Therapeutics

Regulatory Affairs Director (US)Chemours

VP Regulatory AffairsAllucent

Intern Regulatory AffairsLanceSoft Inc

Quality Specialist - cGMP Manufacturing - Weekend 1st ShiftAlcami Corporation

Document Processing SpecialistInsight Global

Sr. Quality Specialist - cGMP Manufacturing - Weekend 1st ShiftAlcami Corporation

RN Travel Executive Director SpecialistGentiva Hospice

Clinical Documentation SpecialistIntermountain Health

Sr. Quality Assurance Specialist - 2nd ShiftAlcami Corporation

Sr. Quality Assurance SpecialistAlcami Corporation

Sr. QA Technical SpecialistFujifilm

Training Specialist/Manager, QualityPriovant Therapeutics

Facets ID Card Configuration SpecialistCognizant

EMT-A/B or Paramedic (Medical Specialist)Proesis Biologics, Inc

Adventure Readiness SpecialistRivian

Specialist, Quality Control InstrumentationFujifilm

Financial Contracting SpecialistLedgent Finance & Accounting

Human Resources Compliance SpecialistKimley-Horn

Virtual Pharmaceutical Sales SpecialistSyneos - Commercial - Prod

Leasing SpecialistAvanath

Workplace SpecialistAvalara

Sr. Validations SpecialistAlcami Corporation

Sr. Manufacturing Execution Systems SpecialistFujifilm

Payroll SpecialistMyEyeDr.

Warehouse Specialist 2Fujifilm

Sales Support SpecialistLoparex LLC

Quality Control SpecialistIntegrated Resources, Inc

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