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.
Cardiovascular Specialist - Rex Invasive Heart & Vascular UNC HealthCardiovascular Specialist - Rex Invasive Heart & VascularRaleigh, NC$33.04–$47.50 / hourIf you're passionate about cardiovascular nursing, enjoy working in a high-performing procedural environment, and want to make a difference when every second counts, we'd love to meet you. Our Cardiac Catheterization Laboratory is a high-energy, fast-paced environment where skilled professionals work together to deliver life-saving care when patients need it most.
Regulatory Affairs Specialist (CMC) Zp Group LlcRegulatory Affairs Specialist (CMC)Durham, NC$60,000–$85,000 / yearThe Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle management of pharmaceutical products. This role ensures compliance with applicable regulatory requirements and provides strategic and operational support for CMC documentation and submissions across multiple regions.
Regulatory Affairs Specialist Zp Group LlcRegulatory Affairs SpecialistNCCoordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content. Job Summary: Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team.
Regulatory Affairs Specialist Peregrine TeamRegulatory Affairs SpecialistRaleigh, NCPeregrine 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.
Senior Regulatory Affairs Specialist BioventusSenior Regulatory Affairs SpecialistDurham, NCRequired: Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry. Duties: Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.
Senior Regulatory Affairs Specialist Bioventus IncSenior Regulatory Affairs SpecialistDurham, NCRequired: Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry. Duties: Author and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.
Regulatory Affairs Specialist II The Clorox CoRegulatory Affairs Specialist IIDurham, NC$90,900–$170,100 / yearThis role requires strong cross-functional collaboration, working daily with partners across R&D (e.g., Product Development), Product Safety, Legal, Corporate Quality, Government Affairs, and Consumer Affairs. Work with Consumer Affairs to develop consumer-facing responses, providing regulatory guidance to ensure accuracy, consistency, and appropriate interpretation of product claims, ingredients, and safety information.
NewSr. Regulatory Specialist - Food and Beverages - North America NovonesisSr. Regulatory Specialist - Food and Beverages - North AmericaFranklinton, NC$105,000–$110,000 / yearWe collaborate openly, shareknowledge, and are continuously strengthening digital ways of working to improve the speed, transparency, and consistency of regulatory deliverables. In this role, you will play a critical part in enabling safe, compliant growth across the Food & Beverages sector by transforming complex regulatory requirements into clear, actionable guidance.
Regulatory Planning & CON Specialist UNC HealthRegulatory Planning & CON SpecialistMorrisville, NC$41.45–$59.58 / hourWorking closely with the Director, Regulatory Affairs & Facility Strategy team members, internal stakeholders, and external advisors, this position plays a critical role in shaping narratives, ensuring consistency and accuracy across regulatory submissions, and supporting leadership communications related to regulatory strategy and facilities planning. This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care; except that, if you are currently a UNCHCS State employee already working in a designated shared services department, you may remain a UNCHCS State employee if selected for this job.
NewRegulatory Affairs Specialist (FDA medical device regulation) Fujifilm CorporationRegulatory Affairs Specialist (FDA medical device regulation)Raleigh, NCFor all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program (MDSAP) (ISO 13485/MDSAP).
NewSponsor Dedicated Regulatory & Start-Up Specialist 2 IQVIASponsor Dedicated Regulatory & Start-Up Specialist 2Durham, North CarolinaUnder general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
NewCommunications Specialist Fisher & Phillips LLPCommunications SpecialistRaleigh, NCFisher Phillips is on a growth trajectory and is seeking a dynamic and strategic Communications Specialist to continue the momentum with firmwide communications activities designed to increase visibility, enhance reputation and elevate our brand story. Partner on cross-functional initiatives with the broader Marketing, Communications, Business Development, and Marketing Technology teams, contributing independent judgment to advance the firm’s marketing and business development objectives.
Senior Specialist – Investigations & Regulatory Inspections AmgenSenior Specialist – Investigations & Regulatory InspectionsHolly Springs, North CarolinaWhen completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In addition to the base salary, 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.
Senior Specialist - Investigations & Regulatory Inspections Amgen IncSenior Specialist - Investigations & Regulatory InspectionsHolly Springs, NCWhen completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In addition to the base salary, 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.
NewSponsor Dedicated Regulatory & Start-Up Specialist 2 IQVIA Holdings IncSponsor Dedicated Regulatory & Start-Up Specialist 2Durham, NC$60,300–$157,100 / yearUnder general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
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.
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.
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.
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.
Senior Regulatory Affairs Associate - Generalist Parexel International CorpSenior Regulatory Affairs Associate - GeneralistNCThis role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist / Senior Associate plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements.
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.
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 AskBio IncDirector, Regulatory AffairsNCThis role will provide regulatory direction for preclinical and clinical development of AskBio's product candidates, working closely with cross-functional Regulatory team members, Global Project Teams, subject matter experts, and external partners to ensure regulatory strategies are aligned with applicable health authority requirements and expectations. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease.
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.
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.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyDurham, NC$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
NewAssociate Director or Director, CMC Regulatory Affairs Atsena Therapeutics IncAssociate Director or Director, CMC Regulatory AffairsDurham, NCLead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates Ensure submissions meet regulatory expectations for gene therapy products. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.
Regulatory Affairs Associate/Senior Associate Azurity PharmaceuticalsRegulatory Affairs Associate/Senior AssociateRaleigh, 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 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.
Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals IncRegulatory Affairs Associate/Senior AssociateRaleigh, 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 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.
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.
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.
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.
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?.
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.
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.
Assistant Director of Regulatory Affairs North Carolina Real Estate CommissionAssistant Director of Regulatory AffairsRaleigh, NCFull timeThe role requires strong independent judgment, initiative, public interaction skills, extensive knowledge of state real estate laws and related statutes, and proven leadership and managerial abilities. The position oversees administrative and non‑attorney consumer and information staff, provides training for legal and non‑legal personnel, and performs attorney duties involving complex disciplinary and civil litigation cases.
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.
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.
Regulatory Affairs Assistant Atlantic Medical ManagementRegulatory Affairs AssistantCary, North CarolinaTheir primary focus will be maintaining internal regulatory procedures related to exclusion screenings, employee user accounts, provider directory listings, and other administrative duties as required. The Regulatory Affairs/Support Assistant will perform a variety of responsibilities to support Regulatory Affairs/Compliance department within AMM.
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.
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.
Regulatory Affairs Associate/Senior Associate Azurity Pharmaceuticals - USRegulatory Affairs Associate/Senior AssociateRaleigh, 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 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.
Plasma Regulatory Affairs Associate Grifols SAPlasma Regulatory Affairs AssociateNCExample: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
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.
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.