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 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.
Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) ParexelSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)North CarolinaYou 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.
Sr. Regulatory Affairs Manager Validation & Engineering GroupSr. Regulatory Affairs ManagerNCValidation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Regulatory Affairs Manager (Transplant Diagnostics) Thermo Fisher Scientific IncRegulatory Affairs Manager (Transplant Diagnostics)NCWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities.
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.
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.
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.
US State Regulatory Manager UPL LtdUS State Regulatory ManagerCary, NCDevelop and maintain vital relationships by interacting with state regulatory agencies, trade organizations, grower groups, industry task forces, and trade associations to effectively communicate the Company's regulatory concerns and objectives REQUIRED EDUCATION AND EXPERIENCE: Ideal candidate will possess at least a minimum of a bachelor's degree (ideally within a scientific discipline) with approximately 5 or more years' direct hands-on industry experience in the US State Regulatory matters. Reporting to Region Regulatory Head, North America, the State Regulatory Manager is responsible for new product submissions, product renewals, label amendment changes, state dossier submissions, sales & marketing enablement, and other state regulatory activities, along with professional interaction with the state and/or local regulatory authorities, trade associations, grower groups, customers and industrial partners as required by job function.
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.
Crop Protection Regulatory Manager, US UPL LtdCrop Protection Regulatory Manager, USNCManage & 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. About UPLUPL (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.
NewSenior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSLSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000 / yearThe role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines CSL PlasmaSenior Manager, Regional Regulatory Lead – North America, Seqirus VaccinesHolly Springs, North Carolinap/>The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
NewSenior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines SeqirusSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000 / yearThe role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
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.
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.
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.
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.
QARA Project Manager Teleflex IncQARA Project ManagerMorrisville, NCThe Project Manager helps drive implementation of quality and regulatory projects by maintaining structured project plans, supporting team collaboration, monitoring progress, and ensuring adherence to compliance requirements. Partner with functional teams-including Regulatory, Design Assurance, Quality Operations, Product Quality, and QMS-to document business requirements and support the development of systems and IT tools.
Regulatory Compliance Lead GSK plcRegulatory Compliance LeadNCp>Position 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.
Senior Scientific Review and Medical Communications Manager United Therapeutics CorpSenior Scientific Review and Medical Communications ManagerNCMSL and CPL CNE slide decks and publication reviews Minimum Requirements Doctor of Pharmacy (PharmD), Doctor of Philosophy (PhD) or MD 5+ years of relevant experience Previous industry in Medical Affairs, with promotional material review experience or previous experience in Regulatory (promotional review) or Clinical Development Proven ability to understand and articulate scientific/clinical information Maintain organization-wide awareness in support of therapeutic areas Ability to engage, negotiate, and build strong collaborative relationships with internal partners and stakeholders. Knowledge of and understanding of Veeva (Promomats) Ability to initiate and lead projects Excellent communication and presentation skills Strong attention to detail Ability to work well in a fast-paced environment Proficiency in Word, PowerPoint and Excel Preferred Qualifications Board Certified Medical Affairs Specialist (BCMAS) * Knowledge of and or experience in medical writing Job Location This position will be located in the RTP, NC office of United Therapeutics.
Senior Manager, Clinical Data Management Kriya Therapeutics IncSenior Manager, Clinical Data ManagementMorrisville, NCThe ideal candidate is a proactive and collaborative data management professional who thrives in a fast-paced biotech environment, demonstrates strong operational ownership, and effectively partners across internal teams, CROs, and external vendors to drive high-quality study execution. 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.
Clinical Proposal Strategy Manager Veranex IncClinical Proposal Strategy ManagerRaleigh, NCAs the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. You will partner cross-functionally with Clinical Operations, Business Development, Clinical Data Services, and Subject Matter Experts (SMEs) to develop robust study strategies, timelines, and budgets.
Mgr Quality Validation Guerbet SAMgr Quality ValidationRaleigh, NCWhen you join Guerbet, you : Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols, and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.
NewNorth America Regional Product Manager (Protein Diagnostics) Thermo Fisher Scientific IncNorth America Regional Product Manager (Protein Diagnostics)NC$113,500–$151,300 / yearPartnering closely with Global Product Management, Commercial Leadership, Regional Marketing, Medical & Scientific Affairs, Market Access, Supply Chain, Regulatory Affairs, Quality, Technical Support, and Field Applications, the Regional Product Manager drives revenue growth, market share expansion, and customer satisfaction. The Regional Product Manager leads complex cross-functional initiatives, influences senior stakeholders, and identifies opportunities to accelerate growth, increase product adoption, and improve portfolio performance across North America.
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.
Sr. Manager, Product Quality Assurance Teleflex IncSr. Manager, Product Quality AssuranceMorrisville, NCCoach and support CAPA, NC, & complaint trend owners to ensure QMS compliance, serve as quorum on QMS reviews, including but not limited to CAPA, NCRB, Product Quality or Management Reviews. o Work with global counterparts, especially Teleflex regional regulatory partners, to enact compliant and effective processes that ensure timely processing & submission of complaints in each region.
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.
Senior Clinical Study Manager Veranex IncSenior Clinical Study ManagerRaleigh, NCAs the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. By managing the operational aspects of the trial, a Clinical Study Manager ensures that high-quality data is generated, contributing to the advancement of medical science and the development of new therapies.
Manager, Industry Solutions, Veeva Life Science Deloitte Touche Tohmatsu LtdManager, Industry Solutions, Veeva Life ScienceRaleigh, NC$144,200–$265,600 / 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. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Medicaid & ACA Manager Blue Cross and Blue Shield of Kansas CityMedicaid & ACA ManagerNC$99,440–$124,300 / yearp>The Medicaid & ACA Manager supports the strategic and operational execution of Medicaid and Affordable Care Act (ACA) programs (individual and small group), serving as a critical operational, analytical, and coordination leader while partnering closely with the Director to translate strategy into disciplined execution. Monitor and interpret key ACA performance indicators (e.g., MLR, risk adjustment/coding capture, enrollment trends, utilization and cost drivers) and support ACA specific analyses related to morbidity shifts, affordability, benefit design, etc.
QA Systems Manager Guerbet SAQA Systems ManagerRaleigh, NCWhen you join Guerbet, you : Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world, Are joining a company where we value diversity of talents coming from various horizon. The manager will lead cross-functional initiatives to enhance documentation, training, change control, Data Integrity, Supplier Management, APQR management, Risk Management, Supplier Quality and audit readiness.
Life Science Veeva Senior Manager Deloitte Touche Tohmatsu LtdLife Science Veeva Senior ManagerRaleigh, NC$189,200–$372,900 / 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. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
Life Sciences Supply Chain and Operations - Supply Chain Planning Manager Accenture PlcLife Sciences Supply Chain and Operations - Supply Chain Planning ManagerRaleigh, NCAs part of working with clients you will help with several aspects of life sciences integrated planning including: Integrated Planning Strategy: Design and implement IBP/S&OP frameworks tailored to life sciences environments, accounting for regulatory release cycles, CMO/CDMO network complexity, and the distinct planning dynamics of biopharma and med tech product portfolios. Accenture is a leading solutions and services company that helps the world's leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, bringing together the talent of our approximately 786,000 people, our proprietary assets and platforms, and deep ecosystem relationships.
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.
Global Product Manager Teleflex IncGlobal Product ManagerMorrisville, NCThis role actively partners with the North America Sales and Leadership teams, Global Marketing counterparts, and cross-functional stakeholders to ensure the execution and implementation of marketing strategies for the Anesthesia and Specialty Markets portfolio. We equip clinicians with some of the most advanced medical devices on the market today, from our world-class brands including: LMA and Rüsch airway management devices designed to help reduce the risk of airway-related complications.
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.
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.
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.
External Quality Operation Manager (GMP) Swedish Orphan Biovitrum ABExternal Quality Operation Manager (GMP)Raleigh, NC$130,000–$153,000 / yearThis role offers the opportunity to work cross-functionally with Manufacturing, Supply Chain, Technical Operations, and Regulatory Affairs, strengthening Sobis commitment to delivering high-quality medicines to patients worldwide. Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement.
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 Thermo Fisher Scientific IncDirector, Regulatory AffairsNC$175,000–$219,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards.
Senior Regulatory Affairs Consultant - Ad Promo Parexel International CorpSenior Regulatory Affairs Consultant - Ad PromoNCThis role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk. We are seeking a highly strategic and experienced Senior Regulatory Consultant - Advertising & Promotion to serve as a trusted advisor across cross-functional teams.
Senior Medical Director , US Immunology Medical Affairs Swedish Orphan Biovitrum ABSenior Medical Director , US Immunology Medical AffairsRaleigh, NC$260,000–$295,000 / yearli>Develop 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.
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.
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.
Senior Manager, Project Management Grifols SASenior Manager, Project ManagementNCD., Masters or Bachelors in a Scientific field 8 years relevant experience Must have worked on or experience leading several multi-functional teams that delivered either new products or extensions of existing products from concept through clinical evaluation or licensing Must have delivered complex strategic/scientific presentation to Senior Management with acceptance Should have worked with key marketing and R&D functions to generate a Business Case for either a new product or extension to existing product that included such items as marketing data, P&L statement, impact on organization, etc. Provides oversight to the financial planning and tracking for the assigned projects in terms of budgets and resources Responsible for fulfilling communication requirements of the organization including project status and the timely escalation of any issues to the Head of PMO, sponsors, key stakeholders and project steering committees Develops SMART objectives for project team members.