82 Results for

Regulatory Affairs Jobs in Raleigh, NC

Jobs

New!

Holly Springs, NC6 days ago

$154,000–$182,000

The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.

Creedmoor, NC18 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.

Creedmoor, NC18 days ago

New!

Youngsville, NC6 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, NC18 days ago

Morrisville, 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

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. Brief team/department description: As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.

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

Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.

Durham, NC7 days ago

The company is seeking a Director or Senior Director of Regulatory Affairs — with the final title set according to the selected candidate's background — to help shape and steer the execution of worldwide regulatory strategy across assigned programs, keeping all work consistent with applicable national and regional requirements as well as internal policy. Direct the assembly of regulatory filings, overseeing the planning, coordination, drafting, and review of every submission sent to health authorities worldwide — including INDs, CTAs, BLAs, MAAs, amendments, replies to questions and information requests, safety reports, and annual updates/DSURs for assigned projects.

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

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.

Raleigh, NC30+ days ago

Brief Team/Department Description: 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. Principle Responsibilities: • 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.

Raleigh, NC30+ 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.

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.

Research Triangle Park, NC30+ days ago

$21–$22 Per Hour

Minimum RequirementsCurrently 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.

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, NC30+ days ago

Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration. Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements.

Raleigh, NC20 days ago

Remote

10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.

Raleigh, NC30+ days ago

Full-time

We are seeking a highly motivated Global Medical Affairs Strategic Research Intern to support our Global Medical Affairs team in strategic research initiatives across clinical, scientific domains involving aesthetic injectables and energy-based devices. This internship offers hands-on experience within a global, cross-functional medical affairs organization, providing exposure to evidence generation, scientific information synthesis, and strategic decision-making in a regulated healthcare environment.

Morrisville, NC30+ days ago

Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

Morrisville, NC30+ days ago

Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. Selecting us as an employer secures a career in which you're guaranteed to: Collaborate with passionate problem solvers Partner with the most diverse team of experts in the industry.

Morrisville, NC30+ days ago

Our products impact public utilities, industrial sectors, residential areas, and commercial buildings, with a commitment to providing smart metering, network technologies, and advanced analytics for water, electric, and gas utilities. Experience using regulatory compliance testing equipment such as: • Anechoic RF chambers • Spectrum analyzers • Oscilloscopes • Signal generators • EFT/Surge and ESD testing equipment.

Raleigh, NC30+ days ago

Manager Regulatory Compliance Job SummaryThe Manager Regulatory Compliance will lead a team of analysts to provide guidance and management of regulatory reporting requirements in all states with Insurance Departments Surplus Lines Associations and Bureaus for admitted and surplus lines entities. We are proud of being recognized the past 5 years as one of The Top Workplaces USA.James River Group Holdings Ltd. is a Bermuda-based insurance holding company which owns and operates a group of specialty insurance and reinsurance companies.

Raleigh, North Carolina25 days ago

Primary responsibilities include but are not limited to the submission of new and renewal applications, student performance data to various oversight agencies, maintaining point of contact information for oversight agencies, processing employment verifications, and distribution of internal compliance updates. The company partners with workforce organizations, healthcare providers, and academic institutions to help build talent pipelines and provide pathways to career advancement, including opportunities for articulated college credit.

Raleigh, NC30+ days ago

Remote

Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies. Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies.

Raleigh, NC28 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, NC30+ days ago

Remote

As a Medical Director at ICON, you will play a pivotal role in driving medical initiatives within project teams, guiding strategic direction and decision-making processes, and offer expert medical and scientific guidance, leveraging therapeutic expertise to inform project development. • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Holly Springs, NC30+ days ago

Remote

This role is an individual contributor position (no people management), but it requires strong independent leadership, sound scientific judgment, and the ability to work effectively in a matrixed Medical Affairs environment. This is a senior, hands-on role for an epidemiologist or RWE professional who can quickly step in and assume ownership of ongoing Phase IV and post-approval real-world evidence studies.

Smithfield, NC30+ days ago

Full-time

Demonstrates a high degree of financial acumen as it relates to community operations; works to meet or exceed budgeted revenue and profitability; and proactively creates plans to overcome unanticipated expenses or revenue shortfalls. Drives sales and marketing efforts in collaboration with community sales leader to meet or exceed occupancy or revenue targets by developing new business, generating leads, and building strategic relationships.

Raleigh, North Carolina25 days ago

The QISG team brings together Engineering, Safety, Quality, Material Procurement, QA/QC, Right-of-Way Acquisition, Scheduling, Environmental Planning, Permitting, Title and Land Management expertise that ensure outstanding results for our clients. What You'll Bring: Minimum of 15 years’ experience in the electric utility industry performing engineering related duties and/or management for high voltage electrical projects.

Raleigh, NC30+ days ago

Remote

MSL) at Compass Pathways is a core member of the Medical Affairs organization, connecting the company's science with the broader mental health and neuroscience community, helping to shape medical strategy, and supporting the continued development of Compass Pathways' work in treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). The ideal candidate is passionate about a field-based role establishing themselves as a key point of scientific contact, actively engaging in high-quality scientific exchange and gathering insights from the field on emerging research, changes in the treatment landscape, and evolving approaches to care.

New!

Morrisville, NC3 days ago

Additional responsibilities include performing data verification activities to ensure accuracy and traceability of source data, supporting regulatory filing documentation, and developing Master Sample Matrices (MSM) used by manufacturing personnel during production floor operations. Direct experience authoring and/or reviewing GMP manufacturing documentation such as Process Performance Qualification (PPQ) protocols and reports, technical reports, validation documentation, investigation reports, process transfer documentation, manufacturing support documents, or regulatory submission content.

Durham, NC30+ days ago

$77,898–$124,598 Per Year

All Duke University remote workers must reside in one of the following states or districts: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington (State), Washington, DC. The Research Agreements Associate, Senior, also provides the Associate Director, and Senior Leadership with expertise in federal contracting processes, assists in the development of SOPs and technical tools for the management of federal contracts, and provides educational sessions for Dukes research-oriented community.