Compliance Specialist StefaniniCompliance SpecialistRaleigh, NC$25–$29 / hourTemporaryContractorOur presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Change Management Support: Represent business operations in change-management discussions by providing operational supporting documentation updates and helping ensure implementation activities align with established QARA guidance.
Chief Deputy Legal Counsel North Carolina Real Estate CommissionChief Deputy Legal CounselRaleigh, NCFull timeRepresents Commission in civil litigation proceedings at State level; prepares documents such as discovery, interrogatories, and depositions; drafts pleadings; prepares witnesses; prepares and presents arguments before judge; prepares and argues various appropriate legal motions; and may participate in jury selection in limited cases and defend cases before a jury under the supervision of the Director and/or Assistant Director of Regulatory Affairs. Prepares and responds to assigned disciplinary and litigation cases; conducts necessary research on real estate and interrelated laws relating to Commission cases and court rulings; determines merits of a case and points of law; analyzes pertinent statutory, common and case law, administrative and procedural rules; develops case strategy and legal arguments.
Family Nurse Practitioner / Physician Assistant - $5,000 Sign - On Bonus Fast Pace HealthFamily Nurse Practitioner / Physician Assistant - $5,000 Sign - On BonusPittsboro, NCPosting Title: Family Nurse Practitioner / Physician Assistant - $5,000 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.
Regulatory Affairs Manager BioventusRegulatory Affairs ManagerDurham, NCWorks with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products. Key Responsibilities: Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned products.
Regulatory Affairs Manager - CMC & Labeling United Therapeutics CorporationRegulatory Affairs Manager - CMC & LabelingRaleigh, NCDirect and manage direct reports to include responsibilities for training, goal setting and achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed). 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.
NewSenior Manager, Regulatory Affairs Azurity PharmaceuticalsSenior Manager, Regulatory AffairsRaleigh, NCBrief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. 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.
NewSenior Manager, Regulatory Affairs Azurity Pharmaceuticals IncSenior Manager, Regulatory AffairsRaleigh, NCBrief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. 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.
NewSenior Manager, Regulatory Affairs Azurity Pharmaceuticals - USSenior Manager, Regulatory AffairsRaleigh, NCAs a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. 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.
NewSenior Manager, Regulatory Affairs Azurity Pharmaceuticals - IndiaSenior Manager, Regulatory AffairsRaleigh, NCAs a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. 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.
Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) Parexel International CorpSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)NCYou will play a key leadership role in managing midsize to large Regulatory Affairs outsourcing programs, partnering closely with clients and cross-functional teams to drive operational excellence, ensure delivery against regulatory objectives, and support the successful progression of development and commercial programs. Due to continued growth and the ongoing success of our Regulatory Affairs Consulting team, Parexel is seeking an experienced Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) to join our team.
Manager Regulatory Affairs Bioventus IncManager Regulatory AffairsDurham, NCWorks with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products. Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.
Senior Regulatory Affairs Consultant - Regulatory Project Manager Parexel International CorpSenior Regulatory Affairs Consultant - Regulatory Project ManagerNCYou will be accountable for driving regulatory excellence by aligning cross-functional stakeholders, managing complex timelines, and anticipating challenges to enable successful delivery of regulatory milestones that support sponsor's mission to bring transformative vaccines to patients worldwide. This role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing.
Manager, Regulatory Affairs Advertising and Promot AA2ITManager, Regulatory Affairs Advertising and PromotRaleigh, NC$60–$80 / hourRepresent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and possess a thorough knowledge of regulations for advertisement and promotional compliance governing device products (drug product experience acceptable) and the ability to translate regulatory requirements into decision-ready guidance for stakeholders. Kindly share resume with answer: Q1: How many yers of direct Regulatory Advertising & Promotion review experience for the U.S. market?.
Manager/Sr. Manager, Regulatory Affairs (Labeling) Grifols SAManager/Sr. Manager, Regulatory Affairs (Labeling)Clayton, NCSummary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.
Sr. Manager-Director, Regulatory Affairs (Respiratory) Integrated Resources, IncSr. Manager-Director, Regulatory Affairs (Respiratory)Raleigh, North CarolinaFull timeSciencesExperience:Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy8 + years total, and in MDI aerosol generics – 5+ yearsExperience with regulatory agency interactions and preparation of documents for regulatory agency interactions Manager-Director, Regulatory Affairs (Respiratory)A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Sr. Director, Strategic Regulatory Affairs and UDI Teleflex IncSr. Director, Strategic Regulatory Affairs and UDIMorrisville, NC$203,000–$253,000 / yearThe position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth. The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.
Director, Regulatory Affairs - Clinical Strategy Azurity PharmaceuticalsDirector, Regulatory Affairs - Clinical StrategyRaleigh, NCPrinciple 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. 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.
Head of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred) BASF SEHead of US Crop Protection Regulatory Affairs - Research Triangle Park, NC (preferred)NCAs a key member of the APD North American Crop Protection leadership team and industry influencer, you will leverage your connections with management in the commercial, supply chain and development functions and apply your understanding of competitive threats, changing regulatory dynamics, and new technologies to set the regulatory direction that facilitates successful business outcomes. Serving as key interface between US Regulatory and key internal BASF stakeholders, proactively facilitating collaboration and coordination to assure strategic alignment and build relationships with stakeholder groups including EPA, USDA, and trade associations, including leadership.
Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist Parexel International CorpSenior / Regulatory Affairs Consultant - Regulatory Labeling StrategistNCAre you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?. Parexel is seeking an experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership and operational oversight for complex global labeling initiatives.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Durham, NC$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyRaleigh, NCDevelopment 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.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyRaleigh, NCBrief 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.
Regulatory Affairs Consultant - Clinical Regulatory Affairs Parexel International CorpRegulatory Affairs Consultant - Clinical Regulatory AffairsNCThis highly visible role combines regulatory strategy, global project leadership, health authority engagement, and cross-functional collaboration across programs ranging from early clinical development through registration planning and lifecycle management. Manage and support regulatory submissions and maintenance activities, including IND applications, annual reports, safety submissions, CTA-related activities, protocol amendments, informed consent updates, and end-of-trial deliverables.
Vice President, Global Head Of Regulatory Affairs Azurity PharmaceuticalsVice President, Global Head Of Regulatory AffairsRaleigh, NCAs 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 company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals IncVice President, Global Head of Regulatory AffairsRaleigh, NCAs 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 company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - USVice President, Global Head of Regulatory AffairsRaleigh, NCAs 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 company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Director, Regulatory Affairs CMC ProPharma Group Holdings LLCDirector, Regulatory Affairs CMCRaleigh, NCThe Director, Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne's development programs, from early-stage development through commercialization and post-approval lifecycle management. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
NewSenior Manager, Strategy - Medical Affairs Azurity PharmaceuticalsSenior Manager, Strategy - Medical AffairsRaleigh, NCRemoteMedical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. 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.
NewSenior Manager, Strategy - Medical Affairs Azurity Pharmaceuticals IncSenior Manager, Strategy - Medical AffairsRaleigh, NCMedical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. 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.
NewSenior Manager, Strategy - Medical Affairs Azurity Pharmaceuticals - USSenior Manager, Strategy - Medical AffairsRaleigh, NCRemoteMedical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. 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.
Senior Manager/Associate Director, Environmental Affairs Cypress Creek Renewables LLCSenior Manager/Associate Director, Environmental AffairsDurham, NCProvide subject matter expertise support during financing, which would include responding to Independent Engineers and external legal counsel comments, advising on contractual terms and conditions for environmental risk, and supporting internal legal, tax, and finance teams to compile environmental documentation. Directly oversee scoping and managing complex, environmental regulatory compliance processes, such as targeted environmental resource studies (e.g., wetland delineations, Phase I ESAs, cultural resource surveys), environmental permitting, and mitigation negotiation, within the Company and with outside consultants.
Manager, Medical Affairs Operations Medela LLCManager, Medical Affairs OperationsRaleigh, NCThis role is a critical connector across Medical Affairs, Clinical, Sales, Marketing, and external healthcare partners to ensure successful delivery of scientific and educational programs that improve outcomes in maternity and neonatal care. This person will lead the execution of global Medical Affairs programs, educational initiatives, and real-world evidence activities supporting healthcare professionals and customers worldwide.
Manager, Medical Affairs Operations MedelaManager, Medical Affairs OperationsRaleigh, NCThis role is a critical connector across Medical Affairs, Clinical, Sales, Marketing, and external healthcare partners to ensure successful delivery of scientific and educational programs that improve outcomes in maternity and neonatal care. This person will lead the execution of global Medical Affairs programs, educational initiatives, and real-world evidence activities supporting healthcare professionals and customers worldwide.
Leader Medical Affairs Canon USA & AffiliatesLeader Medical AffairsRaleigh, NCRemote10 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.
Senior Medical Director , US Immunology Medical Affairs Swedish Orphan Biovitrum ABSenior Medical Director , US Immunology Medical AffairsRaleigh, NC$260,000–$295,000 / yearDevelop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales and Marketing, Global product leadership, Global medical affairs, and clinical development, providing strategic medical insight and product/disease-state expertise to meet business objectives. Additionally, the Senior Medical Director will be a key contributor to the global life cycle management-led activities, including programs for future indications, cytokine testing, Investigator-Initiated Study strategy, and overall input into the creation and execution of product evidence generation plans.
Executive Director, Clinical Development & Medical Affairs Humacyte IncExecutive Director, Clinical Development & Medical AffairsDurham, NCCOMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.
Sr Manager, Regulatory Labeling and Ad Promo IRESr Manager, Regulatory Labeling and Ad PromoRaleigh, North CarolinaRemoteBuilds and maintains strong collaborative relationships with key internal and external (client) stakeholders, including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization. In this role, you will support pre- and post-market label development and lifecycle maintenance, provide expert regulatory review of advertising and promotional materials, and contribute to artwork development that supports successful development, marketing applications, and implementation for drugs, devices, and combination products.
Sr Manager, Regulatory Labeling and Ad Promo ICON PlcSr Manager, Regulatory Labeling and Ad PromoRaleigh, NCRemoteBuilds and maintains strong collaborative relationships with key internal and external (client) stakeholders, including Global Regulatory leadership team, Safety, Quality, Commercial, Medical Affairs, Advertising & Promotion, Global Development, Legal, Manufacturing, Supply Chain and other functions key to the success of product development and commercialization. In this role, you will support pre- and post-market label development and lifecycle maintenance, provide expert regulatory review of advertising and promotional materials, and contribute to artwork development that supports successful development, marketing applications, and implementation for drugs, devices, and combination products.
Junior Regulatory Project Manager - US Country Labelling GSK plcJunior Regulatory Project Manager - US Country LabellingDurham, NCPlease note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. The major outputs of this position are Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and GSK Matrix Teams.
US Regulatory Manager UPL LtdUS Regulatory ManagerCary, NCManage & deliver on regulatory requirements & applications towards new technical and end use product registrations, re-evaluations, label modifications, source changes, data call-ins, import tolerances, and all EPA PRIA and non-PRIA actions to maintain, defend, and expand uses for UPL brand products. UPL (NSE: UPL & BSE: 512070, LSE: UPLL) is focused on emerging as a premier global provider of total crop solutions designed to secure the world's long-term food supply.
US Regulatory Manager UPL Ltd.US Regulatory ManagerCary, NCManage & deliver on regulatory requirements & applications towards new technical and end use product registrations, re-evaluations, label modifications, source changes, data call-ins, import tolerances, and all EPA PRIA and non-PRIA actions to maintain, defend, and expand uses for UPL brand products. UPL (NSE: UPL & BSE: 512070, LSE: UPLL) is focused on emerging as a premier global provider of total crop solutions designed to secure the world's long-term food supply.
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology GSK plcSr Director and Team Lead, Regulatory Labelling Strategy and Development, OncologyDurham, NC$221,925–$369,875 / yearItalian Salary Range / Fascia retributiva in Italia: EUR 123,000 to EUR 205,000Belgium Salary Range / Fourchette salariale - Belgique: EUR 141,750 to EUR 236,250The annual gross base salary range for new hires in this position is listed above for each applicable location. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.
Regulatory Compliance Lead GSK plcRegulatory Compliance LeadZebulon, NCPosition Summary: This role leads a team of professionals acting as advisor, facilitator and team member regarding regulatory compliance and pertinent quality systems for all aspects of the manufacturing, testing, storage and distribution of pharmaceutical products. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Information Systems Sr. Manager - Technology Regulatory Compliance Lead Amgen IncInformation Systems Sr. Manager - Technology Regulatory Compliance LeadHolly Springs, NC$147,259–$174,934 / yearThe professional we seek is an individual with these qualifications: Basic Qualifications: • Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience • Master's degree and 4 years of Information Systems/Technology and/or Engineering experience • Bachelor's degree and 6 years of Information Systems/Technology and/or Engineering experience • Associate's degree and 10 years of Information Systems/Technology and/or Engineering experience • High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Information Systems Sr. Manager – Technology Regulatory Compliance Lead AmgenInformation Systems Sr. Manager – Technology Regulatory Compliance LeadHolly Springs, North CarolinaAmgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Manager, Regulatory Compliance James River HoldingsManager, Regulatory ComplianceRaleigh, NC$101,100–$151,700 / yearContinuously exhibit and uphold Core Values of Integrity, Accountability, Communication and Teamwork, Innovation and Customer ServiceProvide oversight, guidance and hands-on assistance with: Identification, implementation and maintenance of annual and quarterly regulatory filing requirements in all states for surplus lines and admitted entities, necessary to remain in good standingComplete documentation of all filings in network files and Compliance DashboardProper management of Secretary of State filings for insurance entities and management companiesClaims Adjuster licensing and agent appointments/terminationsService of Process and consumer complaintsPremium reporting requirements for surplus lines insurers. Ensure a high level of compliance in all jurisdictions including the ability to meet required deadlines with no fines or penaltiesProvide proper review and sign off on all filings submittedEnsure that project and department milestones and goals are metGuide and help team members with project issuesResponsible for day-to-day tactical team decisionsCollaborate with staff to establish development plansProvide employee feedback through regular check-ins and writing and delivering performance reviewsOther duties as required by management.
NewSenior Regulatory Compliance Manager Circle Internet Financial LLCSenior Regulatory Compliance ManagerRaleigh, NCRemote$172,500–$222,500 / yearWhat you'll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global function focused on developing a best in class compliance management system, supporting all regional and core compliance team functions. Circle's platform includes the world's largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet.
Senior Associate, Regulatory CMC Humacyte IncSenior Associate, Regulatory CMCDurham, NCRemoteDemonstrate and apply thorough understanding of U.S. FDA, EU, and Rest of World (ROW) regulations with respect to aseptic processing, biologics manufacturing, market authorization, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, 1271; and relevant European Directives (EudraLex Volume 4, 2001/83/EC, 2004/23/EC). COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine.
NewAssociate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Atsena Therapeutics IncAssociate Director or Director, Regulatory Strategy (Clinical & Nonclinical)Durham, NCLead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions Ensure high-quality regulatory documentation aligned with agency expectations. 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.
NewRegulatory Strategy Consultant Parexel International CorpRegulatory Strategy ConsultantNCWith 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. As a Regulatory Strategy Consultant, you will own regulatory strategy across significant programs and portfolios, providing leadership for major regulatory decisions, authority engagement models, and high-impact submissions.