NewAssociate Regulatory Attorney - Raleigh North Carolina Education LotteryAssociate Regulatory Attorney - RaleighRaleigh, NC$87,559–$98,504Full timeThe North Carolina State Lottery Act (Chapter 18C in the North Carolina General Statutes) establishes the Commission not only to oversee the operation of the state-run lottery, but also to regulate other sanctioned gaming to generate funds for the state. The North Carolina State Lottery Commission has an early-career opportunity for an ambitious, curious attorney ready to do consequential work – advising investigators, influencing enforcement strategy, and helping build one of the Southeast's most dynamic regulatory bodies.
NewCommercial Real Estate Loan Specialist First Horizon BankCommercial Real Estate Loan SpecialistRaleigh, NCThe 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.
NewMember Business Lending Operations Specialist Local Government Federal Credit UnionMember Business Lending Operations SpecialistRaleigh, NCMonitors daily interactions with outside vendors related to loan operations services, including attorney’s, title companies, state and county offices, insurance and lien filing providers pertaining to collateral and liaison to other internal departments. Minimum 1-3 years of Member Business loan operations experience in all aspects of servicing and loan documentation preparation for commercial non-real estate, real estate and construction loans/lines of credit, including participations (bought and sold).
NewMedical Lab Specialist - Microbiology Laboratory UNC HealthMedical Lab Specialist - Microbiology LaboratoryChapel Hill, NC$31.04–$44.62 / hourThe Specialist works in collaboration with the laboratory supervisor and laboratory directors to address analytical problems and maintain scientific oversight of routine patient testing. The Microbiology Laboratory is currently recruiting a Medical Laboratory Specialist for the Central Processing, Bacteriology, and Special Microbiology areas of the laboratory.
Cardiovascular Specialist - Rex Invasive Heart & Vascular UNC HealthCardiovascular Specialist - Rex Invasive Heart & VascularRaleigh, NC$33.04–$47.50 / hourOperates 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.
NewRegulatory 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.
NewRegulatory 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.
Sr. Regulatory Affairs Specialist Bioventus IncSr. Regulatory Affairs SpecialistDurham, NCThe Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. 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.
Senior Regulatory Affairs Specialist - Plant Health NovonesisSenior Regulatory Affairs Specialist - Plant HealthDurham, North CarolinaAs a Senior Regulatory Affairs Specialist, you will play a key role in shaping regulatory strategies that enable the successful development and commercialization of biofertilizers, plant inoculants, and biocontrol solutions. As part of our Global Regulatory Affairs function, you will join a collaborative and high-impact team supporting the registration and legal sale of Plant Biosolutions worldwide.
NewSr. Regulatory Affairs Specialist BioventusSr. Regulatory Affairs SpecialistDurham, NCThe Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. 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 Peregrine TeamRegulatory Affairs SpecialistRaleigh, North CarolinaPeregrine 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.
Regulatory Planning & CON Specialist UNC HealthRegulatory Planning & CON SpecialistMorrisville, NC$41.45–$59.58 / hourp>Working 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.
QC Regulatory & Stability Area Specialist Novo Nordisk ASQC Regulatory & Stability Area SpecialistDurham, NCOur Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. For over 100 years, weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives.
Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics United Therapeutics CorpRegulatory Affairs Manager / Senior Regulatory Affairs Manager - BiologicsNCProvide regulatory support for assigned products/projects, coordinating cross-functional activities with various UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to support execution of regulatory activities and adherence to established timelines. The Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics will lead regulatory activities for assigned existing and new programs, supporting product development from early development through post-approval.
Regulatory Affairs Associate Actalent IncRegulatory Affairs AssociateClayton, NC$28–$35 / hourThe culture emphasizes collaboration, integrity, and continuous learning, offering strong training resources, exposure to advanced scientific and regulatory practices, and a supportive environment where your work directly contributes to improving patient lives. You will work in a professional office environment that supports plasma regulatory affairs activities, using tools such as Microsoft Office (Word, Excel) and Adobe PDF for document creation, editing, and formatting.
Associate Director, Regulatory Affairs Baxter International IncAssociate Director, Regulatory AffairsRaleigh, NC$176,000–$242,000 / yearRecruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.).May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
NewSenior Manager, Regulatory Affairs (Ad Promo) ICON PLCSenior Manager, Regulatory Affairs (Ad Promo)Raleigh, NCContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices . Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
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 Manager, Regulatory Affairs (Ad Promo) IRESenior Manager, Regulatory Affairs (Ad Promo)Raleigh, North CarolinaContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
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.
Associate Director, Regulatory Affairs (CMC) Kriya Therapeutics IncAssociate Director, Regulatory Affairs (CMC)Morrisville, NCThe 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.
Intern Regulatory Affairs Leadstack IncIntern Regulatory AffairsResearch Triangle Park, NC$21–$22 / hourMinimum 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.
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 (Senior Director), Regulatory Affairs Shattuck Labs IncDirector (Senior Director), Regulatory AffairsDurham, NCIncluded among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.
Associate Director, Regulatory Affairs (CMC) Kriya TherapeuticsAssociate Director, Regulatory Affairs (CMC)Research Triangle Park, NCThe 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.
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.
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.
Plasma Regulatory Affairs Associate The Kemtah Group, Inc.Plasma Regulatory Affairs AssociateDurham, NC$28–$35 / hourAbility to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications. Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
Regulatory Affairs Associate (entry level) Grifols SARegulatory Affairs Associate (entry level)NCExample: 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.
Plasma Regulatory Affairs Associate Grifols SAPlasma Regulatory Affairs AssociateResearch Triangle Park, NCExample: 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.
Senior/Director - Regulatory Affairs implaionSenior/Director - Regulatory AffairsDurham, NCThe 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.
Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase Syneos Health IncSenior Medical Writer - Regulatory Documents - CSR /Protocol - Late PhaseMorrisville, NCInteracts 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.
Regulatory Affairs Project Manager, US Remote Fortrea IncRegulatory Affairs Project Manager, US RemoteDurham, NCRemote$115,000–$130,000 / yearThe Regulatory Affairs Project Manager will be responsible for developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs Merz North America IncSenior Director, Advertising and Promotional Compliance Lead - Global Regulatory AffairsRaleigh, NCThe individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders. Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsDurham, NC$113,850–$189,750 / yearGSK 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. Please 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.
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.
Senior Manager, Regulatory Strategy ICON PlcSenior Manager, Regulatory StrategyRaleigh, NCContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
Plasma Regulatory Affairs Associate Belcan LLCPlasma Regulatory Affairs AssociateDurham, NC$28–$35 / hourli>Ability to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications. Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
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.
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.
Plasma Regulatory Affairs Associate BelcanPlasma Regulatory Affairs AssociateDurham, NC$28–$35 / hourAbility to successfully interact with regulatory bodies and cross-functional teams through professional, articulate, and courteous conversations and clear, concise written communications. ● Educate and inform internal customers at the corporate office and at the plasmapheresis centers regarding regulatory requirements as it pertains to licensing activities.
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.
Senior Consultant, Health Insurance - Risk Regulatory & Compliance Deloitte Touche Tohmatsu LtdSenior Consultant, Health Insurance - Risk Regulatory & ComplianceRaleigh, NC$118,700–$218,600 / yearThe wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Experience applying International Classification of Diseases, Tenth Revision (ICD-10), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) in claims, medical record, or appeals reviews.
NewConsultant, Rates & Regulatory Job Details | Black & Veatch Family of Companies Black & VeatchConsultant, Rates & Regulatory Job Details | Black & Veatch Family of CompaniesCary, NCRecognized by Glassdoor as a 2023 Top 100 place to work and winner of the Newsweek's 2023 America's Greatest Workplaces for Diversity , Black & Veatch allows you to lend your talent and perspective to humanity's biggest challenges in a flexible environment where you are empowered to grow and explore new possibilities. Black & Veatch's Infrastructure Advisory Business provides a portfolio of solutions focused on the asset lifecycle, including Asset Management & Operations & Maintenance, Infrastructure Technology, Cybersecurity Solutions, Planning, and Transactions.
Consultant, Rates & Regulatory Black & Veatch Holding CoConsultant, Rates & RegulatoryCary, NCRecognized by Glassdoor as a 2023 Top 100 place to work and winner of the Newsweek's 2023 America's Greatest Workplaces for Diversity, Black & Veatch allows you to lend your talent and perspective to humanity's biggest challenges in a flexible environment where you are empowered to grow and explore new possibilities. Black & Veatch's Infrastructure Advisory Business provides a portfolio of solutions focused on the asset lifecycle, including Asset Management & Operations & Maintenance, Infrastructure Technology, Cybersecurity Solutions, Planning, and Transactions.
Regulatory Submission Lead GSK plcRegulatory Submission LeadDurham, NCGSK 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. We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline, or equivalent experience.
Global Regulatory CMC Scientist (Raleigh) UCB SAGlobal Regulatory CMC Scientist (Raleigh)Raleigh, NCDefine the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals to meet business needs. Demonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance CMC and Device regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets.
Director of Regulatory - Biological & Traditional Fertilizers The Mosaic CoDirector of Regulatory - Biological & Traditional FertilizersDurham, NCLead global regulatory strategy and product registration activities across North America, Europe, Latin America, and Asia-Pacific; oversee preparation, submission, and lifecycle management of regulatory dossiers (federal/state registrations, REACH, fertilizer/biostimulant regulations); ensure compliance with labeling, safety, environmental, and composition requirements; manage audits, inspections, and regulatory authority interactions for Biosciences and support these functions for traditional fertilizer. The Director of Regulatory Affairs - Biological & Traditional Fertilizers, reporting to the Vice President of Product Innovation, leads the global regulatory strategy, registration, and compliance for a diverse portfolio of conventional fertilizer and biological products, ensuring full adherence to regulatory requirements while enabling innovation, speed to market, and sustained commercial growth.