Regulatory and Quality Specialist - Labware - Millville, NJ Michael Page USARegulatory and Quality Specialist - Labware - Millville, NJVineland, NJ$70,000–$80,000 / yearFull timeThis role is responsible for maintaining quality systems, supporting audits and certifications, managing documentation, ensuring compliance with applicable regulatory requirements, and driving continuous improvement initiatives. With a legacy spanning over 100 years, they are committed to enabling scientific discovery and innovation through high-quality products, robust quality systems, and customer-focused solutions.
Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
Safety Specialist LG CNS AmericaSafety SpecialistEnglewood Cliffs, NJ$100,000–$120,000 / yearFull timeThe Field Safety Professional is responsible to ensure compliance with all regulatory requirements, owner requirements and company policies/procedures on site while being part of a team that will create and cultivate an injury and accident-free work environment. The Field Safety Professional will work within the construction project team and will report to the project manager as well as Safety team in HQ.
Project Controls Specialist StefaniniProject Controls SpecialistNewark, NJ$52–$55 / hourTemporaryContractorOur presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world.
GMP Training Specialist Synerfac Technical StaffingGMP Training SpecialistWhippany, NJ$35–$38.50 / hourTemporaryContractorManufacturing Practice (cGMP) training programs across the site's manufacturing operations, including solid oral dosage (tablet and capsule) production and aseptic fill-finish operations, as well. * Design and deliver training curricula for solid oral dosage manufacturing operations, including granulation, blending, compression, encapsulation, coating, and packaging.
Validation Specialist â Aseptic Process Simulation Synerfac Technical StaffingValidation Specialist â Aseptic Process SimulationWhippany, NJ$42–$45 / hourTemporaryContractorInterface with IQ/OQ/PQ activities for the sterile filling line, SKAN isolator, environmental monitoring systems, and associated critical utilities (compressed air, nitrogen, WFI, clean steam) as they relate to APS readiness. * Establish and maintain APS bracketing and worst-case rationale documentation (e.g., shift duration, personnel interventions, line speed, container-closure configurations).
RCM Product Specialist SOFIERCM Product SpecialistTotowa, NJRemoteThe RCM Product Specialist will lead the development, implementation, and validation of manufacturing and analytical methods of new diagnostic and therapeutic radiopharmaceuticals for SOFIE within the itheranostic / FAPI Division. Working closely with SOFIE’s pharmaceutical partners and internal staff, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211and 212).
DTC Settlements Specialist Page GroupDTC Settlements SpecialistIselin, NJ$50–$55 / hourA DTC Settlements Specialist in the financial services industry will handle the daily processing and reconciliation of securities settlements. This role ensures accurate and timely settlements, working closely with internal teams and external parties.
NewCopilot Studio Specialist CollaberaCopilot Studio SpecialistPennington$70–$73 / hourTemporaryContractorYou’ll help drive enterprise adoption of Copilot Studio by building AI agents, automations, and integrations while ensuring alignment with AI governance and best practices. As a global leader in talent solutions, we provide opportunities to work with top organizations, cutting-edge technologies, and dynamic teams.
NewMedical Billing Specialist Gottlieb and GreenspanMedical Billing SpecialistFair Lawn, NJ$60,000–$65,000 / yearWe are Gottlieb & Greenspan — a growing boutique law firm in Bergen County with a collaborative team and a workplace grounded in our core values: we are ethical, respectful of all people, accountable, positive and fun, driven, and committed to excellence . As a Medical Invoicing Specialist, you will play a key role in managing the firm's receivables: tracking outstanding balances, coordinating with healthcare providers and payers, and helping ensure accurate, timely billing.
Project Controls Specialist AxelonProject Controls SpecialistNewark, NJMinimum 5 years of experience in project controls, cost engineering, or financial analysis, ideally within utilities, energy efficiency, or infrastructure programs. Support audit and regulatory readiness by maintaining clear documentation of cost and workflow processes.
NewChart Retrieval Specialists AxelonChart Retrieval SpecialistsNewark, NJ$30–$40 / hourThis is achieved by serving as the primary member of a team made up of people from various functional areas in the end-to-end provider experience process and is responsible to support chart retrieval collection throughout New Jersey and surrounding areas. 2.Informs and educates providers and physicians on clients chart collection activities and is responsible for fostering provider relationships and adoption of client Risk Adjustment initiatives.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
NewSenior Director, Global Oncology Medical Affairs Daiichi Sankyo, Inc.Senior Director, Global Oncology Medical AffairsBasking Ridge, NJ$242,700–$404,500 / yearFull timeResponsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound or therapeutic area and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. The Senior Director, Global Oncology Medical Affairs is responsible for developing the Global Medical Affairs (GMA) strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management for the assigned compound and will report into the Global Oncology Medical Affairs Franchise Head.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Quality / Regulatory Specialist-Millville, NJ Michael Page InternationalQuality / Regulatory Specialist-Millville, NJVineland, New Jersey$70,000–$80,000 / yearFull timeThe successful Quality & Regulatory Specialist will have:Bachelor's degree in Quality Assurance, Chemistry, Biology, Engineering, Regulatory Affairs, or a related scientific discipline. Relevant work experience will also be considered.1-5 years of experience in quality assurance, regulatory affairs, manufacturing quality, or a related role.
Senior Specialist, Regulatory Affairs ImmunityBioSenior Specialist, Regulatory AffairsSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Staff Specialist, Regulatory Affairs Stryker CorpStaff Specialist, Regulatory AffairsMahwah, NJRemote$77,700–$129,500 / yearHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
Regulatory Affairs Specialist Amneal Pharmaceuticals IncRegulatory Affairs SpecialistPiscataway, NJ$117,000–$120,000 / yearRegulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. Assists in organizing meetings with FDA including compilation of meeting requests and briefing packages with cross functional contributors.
Senior Regulatory Affairs Specialist Integrated Resources, IncSenior Regulatory Affairs SpecialistJersey City, New JerseyFull timeSenior Regulatory Affairs SpecialistA 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. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products.
Sr. Regulatory Affairs Specialist VB Spine LLCSr. Regulatory Affairs SpecialistAllendale, NJ$100,000–$105,000 / yearAs a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.
Sr. Regulatory Affairs Specialist Integrated Resources, IncSr. Regulatory Affairs SpecialistEdison, New JerseyFull timeRegulatory Affairs SpecialistA 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. This is a Direct Hire role with the clientJob DescriptionJOB SUMMARYThis person will be a Regulatory liaison between product development and the regulatory agencies.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistMahwah, NJ$28–$33 / hourCoordinate, prepare, and review regulatory documents and certifications for example: Specifications, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, BE/GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
NewSr. Staff Regulatory Affairs Specialist VB Spine LLCSr. Staff Regulatory Affairs SpecialistAllendale, NJ$135,000–$145,000 / yearAs a Principal Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll apply broad and advanced knowledge of regulatory frameworks, requirements, and processes to advise cross-functional teams and leadership on complex projects and strategies - supporting global product development, lifecycle management, and regulatory. At VB Spine, join a high-performing Regulatory Affairs team where you'll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsJersey City, New Jersey, United States, New JerseyMonitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The 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.
Regulatory Specialist Air LiquideRegulatory SpecialistFairfield, New Jersey$100,000–$130,000 / yearR10094604 Regulatory Specialist (Open) Location: Fairfield, NJ (Seppic) - Sales - North America zone An Air Liquide Healthcare company, subsidiary of the Air Liquide group, Seppic has been designing, manufacturing, and marketing unique ingredients for over 75 years. Operating at the intersection of regulatory affairs and client relations, this role is critical to managing global documentation requests, ensuring adherence to FDA guidelines, and collaborating closely with internal stakeholders and external manufacturing principals.
["SAP Regulatory Reporting Specialist (Utilities) FERC","SAP Regulatory Reporting Specialist (Utilities) FERC"] covetit["SAP Regulatory Reporting Specialist (Utilities) FERC","SAP Regulatory Reporting Specialist (Utilities) FERC"]EdisonTranslate FERC USoA and state regulatory classifications into SAP master data, cost structures, and reporting logic. • Develop, maintain, and enhance SAP based regulatory reports supporting FERC, NARUC, and state PUC requirements.
Regulatory Affairs Specialist Hybrid Spectrum VascularRegulatory Affairs Specialist HybridBridgewater, NJThis role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics.
Quality & Regulatory Specialist - Lab Packaging - Franklin, NJ Michael Page InternationalQuality & Regulatory Specialist - Lab Packaging - Franklin, NJFranklin, New Jersey$60,000–$85,000 / yearFull timeThe Successful ApplicantHigh school diploma or Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Chemical Engineering, or a related scientific discipline. Experience supporting validation activities such as equipment qualification, process validation, cleaning validation, or computerized systems validation is a plus.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNJ$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Regulatory Specialist (Cosmetics) AtriumRegulatory Specialist (Cosmetics)North Brunswick, NJThe Regulatory Specialist will support regulatory compliance efforts for personal care and cosmetic products by performing raw material coding, managing ingredient documentation, product registrations, testing coordination, and labeling reviews. Coordinate product safety and stability testing, including working with Formulation teams, external labs, protocols, quotations, sample shipments, and final documentation.
Regulatory specialist Integrated Resources, IncRegulatory specialistParsippany-Troy Hills, New JerseyFull timeThe person will support the compilation, tracking, and processing of regulatory documentation (e.g., affiliate requests, technical documentation, regulatory submissions).This individual will, also, be responsible to monitor and track the activities and expenses performed by vendors for Regulatory Operations ensuring a high-level of quality deliverables. Must possess clear verbal and written communication skills, attention to detail, strong organizational and project management skills and ability to problem solve, recognize and find solutions for gaps in processes.
Regulatory Compliance Specialist Integrated Resources, IncRegulatory Compliance SpecialistParsippany-Troy Hills, New JerseyContractorJob DescriptionThis position provides regulatory support in regards to several internal and external processes for the regulatory compliance of clients final products including: ingredient disclosure, Safety Data Sheets, WERCSmart, DOT hazardous materials shipping, US Customs, and the management of DEA controlled substances. Regulatory Compliance SpecialistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Regulatory Documentation Specialist II ImmunityBio IncRegulatory Documentation Specialist IISummit, NJFormat and compile documents according to requirements specified by Regulatory Agencies Publish documents (internal bookmarks and hyperlinks), insert into XML backbone (docuBridge), and complete external hyperlinks to other documents and datasets on the XML backbone Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements Prepare document shells for inclusion of text and data Assist in training Regulatory Documentation Specialists ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Bachelor's Degree in life sciences or technical discipline with 2+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or High school diploma with 6+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required.
Regulatory Documentation Specialist III ImmunityBio IncRegulatory Documentation Specialist IIISummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Regulatory Science Specialist [Mahwah, NJ] Matlen Silver, Inc.Regulatory Science Specialist [Mahwah, NJ]Mahwah, NJOperate and maintain laboratory equipment, ensuring reliability through execution of preventive maintenance, routine performance and calibration checks; demonstrate ability to troubleshoot minor issues. Conducts analysis of environmental and water samples, documents and trends laboratory data, supports OOS investigations, and assists with data review.
Regulatory Compliance Specialist J&J Snack FoodsRegulatory Compliance SpecialistMount Laurel, New JerseyAs a leader and innovator in the snack food industry for over 50 years, J&J Snack Foods provides branded snack foods to foodservice and retail supermarket outlets across the U.S. Its products include such icons as SUPERPRETZEL, ICEE, and Dippin’ Dots along with other key brands like LUIGI’S Real Italian Ice, The Funnel Cake Factory Funnel Cakes, and Hola Churros. ESSENTIAL FUNCTIONS: Verifies label content and provides approval on all finished product labels by applying a thorough knowledge of federal, state, local, and international food labeling requirements.
Regulatory Documentation Specialist II ImmunityBioRegulatory Documentation Specialist IISummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Regulatory Science Specialist JBL ResourcesRegulatory Science SpecialistMahwah, NJJBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Regulatory and Quality Specialist - Cumberland County Michael Page InternationalRegulatory and Quality Specialist - Cumberland CountyVineland, New Jersey$70,000–$80,000 / yearFull timeOn offer for the candidate is:Strong compensation package (salaried) with benefitsGood Manufacturing Site EnvironmentStrong CultureExposure to upper managementLife Sciences/Pharmaceutical Industry ExposureGrowth Opportunityand more Proficient in computer applications (e.g., SAP, Microsoft Office).Strong professionalism, organizational, and time management skills; ability to multitask.
Quality/Regulatory - Senior Specialist Apidel TechnologiesQuality/Regulatory - Senior SpecialistMahwah, NJContractorKey Responsibilities include maintaining the EH&S management system in accordance with internal and regulatory requirements; preparing and delivering EH&S training programs; conducting inspections and audits; preparing EH&S reports and metrics; leading the Emergency Response program; overseeing incident investigations and trend analysis; assessing EH&S impacts of proposed changes; ensuring effective risk assessment and risk reduction programs; monitoring regulatory compliance; managing waste and environmental monitoring programs; leading site EH&S projects; collaborating with site leadership; and promoting a strong culture of safety and environmental accountability. This role serves as a subject matter expert and key contributor to the sites EH&S strategy, supporting and mentoring the organization to ensure effective implementation of EH&S processes aligned with business needs.
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerNJ$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy Insmed IncSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyBridgewater, NJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA.
NewSenior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy InsmedorporatedSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyNew JerseyRemoteYou will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
["Regulatory Affairs Strategist, Globalization (eIPRRA)","Regulatory Affairs Strategist, Globalization (eIPRRA)"] BD (Becton, Dickinson and Company)["Regulatory Affairs Strategist, Globalization (eIPRRA)","Regulatory Affairs Strategist, Globalization (eIPRRA)"]Franklin Lakes$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible forimplementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategiesthrough tools, processes, and best‑practice sharing.
["Regulatory Affairs Strategist, Globalization (US/ EU)","Regulatory Affairs Strategist, Globalization (US/ EU)"] Becton, Dickinson & Company["Regulatory Affairs Strategist, Globalization (US/ EU)","Regulatory Affairs Strategist, Globalization (US/ EU)"]Franklin Lakes$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.
["Senior Manager, CMC Global Regulatory Affairs","Senior Manager, CMC Global Regulatory Affairs"] Otsuka America Pharmaceutical["Senior Manager, CMC Global Regulatory Affairs","Senior Manager, CMC Global Regulatory Affairs"]TrentonThe Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of small molecule and biological/biotechnological products during late-stage development and throughout the commercial lifecycle. Develop and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs, Global Regulatory Strategy, Manufacturing facilities, Global Quality, Technical Operations, Business Development etc.] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.