Classroom Intervention Specialist Abraxas Youth & Family ServicesClassroom Intervention SpecialistMorgantown, PA$0–$25Our employees play a vital role in helping individuals achieve greater independence, confidence, and success while promoting dignity, respect, inclusion, and personal choice. Must pass both federal and state background checks which screen for crimes including, but not limited to drug related crimes, violent crimes, sexual abuse, domestic violence, child abuse, and repeated misdemeanors.
Youth Development Specialist, ORR Abraxas Youth & Family ServicesYouth Development Specialist, ORRMorgantown, PA$25–$28Our employees play a vital role in helping individuals achieve greater independence, confidence, and success while promoting dignity, respect, inclusion, and personal choice. Must pass both federal and state background checks which screen for crimes including, but not limited to drug related crimes, violent crimes, sexual abuse, domestic violence, child abuse, and repeated misdemeanors.
NewPayroll Specialist CFSPayroll SpecialistPittsburgh, PAThis is a great opportunity for a payroll professional who enjoys working in a fast-paced environment, values accuracy, and wants to make an impact supporting employees across the organization. Our client is a well-established organization seeking a Payroll Specialist to join their shared services team.
Principal Engineer – Transmission Scenario Planning - External Analysis Specialist ExelonPrincipal Engineer – Transmission Scenario Planning - External Analysis SpecialistKENNETT SQUARE, PA$122,400–$168,300Develops and/or leads teams in studies, plans, criteria, specifications, calculations, evaluations, design documents, performance assessments, integrated systems analysis, cost estimates, budgets, associated with the planning, design, licensing, construction, operation, and maintenance of Exelon's electric generation, transmission, distribution, gas and telecommunication facilities/systems. We are a Fortune 200 company, 20,000 colleagues strong serving more than 10.7 million customers at six energy companies -- Atlantic City Electric (ACE), Baltimore Gas and Electric (BGE), Commonwealth Edison (ComEd), Delmarva Power & Light (DPL), PECO Energy Company (PECO), and Potomac Electric Power Company (Pepco).
NewHR & Payroll Specialist CFSHR & Payroll SpecialistYork, PA$60,000–$70,000 / yearThis role will be responsible for processing payroll, maintaining employee records, supporting benefits administration, and assisting with various HR initiatives and employee engagement activities. This position is ideal for a payroll professional who enjoys supporting employees, working with HR systems, and contributing to a positive workplace culture.
NewLoan Sales Specialist OneMain FinancialLoan Sales SpecialistCranberry, PAKey Word Tags Sales, Collections, Retail, Loan Sales, Customer Service, Customer Care, Business Development, New Grad, Newly Graduated, Entry level, Financial Sales, Management Development, Management Trainee, Finance, Full-time, Career, Benefits, Customer experience, Financial Representative, Credit, Leadership, Manager Trainee #OMHTF Powered by SonicJobs (an advertiser on Monster). In our more than 1,300 community branches and across the U.S., team members help millions of customers solve critical financial needs, including debt consolidation, home and auto repairs, medical procedures and extending household budgets.
Specialist, Residency Program St. Luke's Health Network, Inc.Specialist, Residency ProgramEaston, PAFull timeCreation, design and implementation of the recruitment plan and time line for the training program, (e.g., number of residents, objectives and subjective criteria for the selection of residents, number of interview dates, notification of faculty that interview applicants and their support staff of the actual dates of the interviews, notification and scheduling of resident participation in the interview process, and preparation of appropriate correspondence to applicants during the recruitment process.). Prepares and maintains academic and administrative records on resident physicians bot past and current that include: all correspondence, experience reports, tracking and reporting of vacation, sick, educational time away (CME), and off services, certification reports, courses attended, CREOG.
Sr. Specialist Regulatory Affairs, Medical Devices West Pharmaceutical Services IncSr. Specialist Regulatory Affairs, Medical DevicesExton, PASpecialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, technical packages. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.
Regulatory Affairs Specialist, Global Quaker HoughtonRegulatory Affairs Specialist, GlobalConshohocken, PASupport chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistPA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
NewRegulatory Specialist - Jefferson Health Plans Thomas Jefferson UniversityRegulatory Specialist - Jefferson Health PlansPhiladelphia, PennsylvaniaJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
Senior Regulatory Affairs Specialist - Animal Health Cencora IncSenior Regulatory Affairs Specialist - Animal HealthPAYou will work closely with internal and client stakeholders across Regulatory Affairs, Quality, Manufacturing, Pharmacovigilance, Supply Chain, and Commercial teams to help ensure regulatory objectives are delivered efficiently and compliantly. This is an exciting opportunity for a regulatory professional who enjoys working across the full product lifecycle and partnering with cross-functional teams to deliver compliant, timely, and high-quality regulatory outcomes.
Sr Specialist, Regulatory Affairs West Pharmaceutical Services IncSr Specialist, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
Principal Specialist, Regulatory Affairs West Pharmaceutical Services IncPrincipal Specialist, Regulatory AffairsExton, PAPreferred Knowledge, Skills and Abilities: • Excellent oral communication and technical writing skills • Advanced knowledge of product life cycle, product development, design control and change control • International regulatory competency • Experience with administration and safety systems preferred • Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745) • History of successful US 510(k) device and EU technical documentation submissions • Experience directly interacting with government agencies • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance) • Experience reviewing product labeling and advertising/promotional material for medical devices • Strong negotiation and decision-making skills • Self-motivated with a proactive attitude and the ability to work effectively • Ability to manage multiple priorities. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.
Specialist 3 - Regulatory Affairs LancesoftSpecialist 3 - Regulatory AffairsWest Chester, PA$1Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices.
Regulatory Specialist Globus Medical IncRegulatory SpecialistPAPosition Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,, preferably within orthopedic medical devices; Experience in medical device development and registration of products.
Sr Regulatory Affairs Specialist Globus MedicalSr Regulatory Affairs SpecialistAudubon, PennsylvaniaPrepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaPA$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.
Specialist 3 - Regulatory Affairs Katalyst Healthcares & Life SciencesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
Sr. Specialist, Regulatory Project Management West Pharmaceutical Services IncSr. Specialist, Regulatory Project ManagementExton, PAThe Senior Specialist, Regulatory Project Management is responsible for leading regulatory project execution for West's global portfolio of medical devices, combination products, software-enabled devices/SaMDs, and packaging components. The role supports FDA premarket submissions (510(k)), EU MDR Technical Documentation, Master Files (DMF/MAF), change notifications, information request responses, post-approval commitments, and post-market regulatory deliverables.
Specialist 3 - Regulatory Affairs Karwell TechnologiesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
NewSenior Regulatory Matters and Licensing Specialist FlagshipSenior Regulatory Matters and Licensing SpecialistChadds Ford, PARemoteFull timeWe are seeking a Senior Regulatory Matters and Licensing Specialist to lead the maintenance, and renewal of company licenses across all 50 states and the District of Columbia while serving as a key liaison with regulatory agencies. As a key member of our Regulatory Affairs team, you will play a critical role in supporting nationwide business operations, influencing compliance strategy, and partnering with leaders across the organization.
Regulatory Affairs Specialist IDE GroupRegulatory Affairs SpecialistPhiladelphia, PAt\t\t \t\t \t\tMenuMedTech SectorsConnected CareDrug DeliveryPoint-Of-Care DiagnosticsRespiratory CareSurgical DevicesCapabilitiesOpportunity DiscoveryBusiness StrategyProduct DevelopmentSoftware SolutionsQuality AssuranceRegulatory AffairsManufacturingMarket Launch & DistributionHuman Factors & Usability EngineeringMedTech Simulation Usability LabProjectsAboutCertifications & ComplianceHow We WorkOur TeamCareersJobsIntern & Grad ProgramsNews & MediaVideos & PodcastsBBFH SeriesPodcastsOther Videos & PodcastsPress ReleasesNews & ArticlesBBFH ChallengeOpportunity & PrizesKey DatesChallengersYour MotivationJudgesWinners 2025Interview SeriesOur ImpactContact\t\t \t\t\t. \t\t\t\t \t\t\t\t \t\t\t\t\tSearch for: \t\t\t\t\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t\t \t\t\t\t\t\t\t\t\t.
Regulatory Specialist Advance Sourcing ConceptsRegulatory SpecialistPittsburgh, PennsylvaniaResearching regulatory issues pertaining to clinical trial protocols, consent forms, progress reports, IRB and drug approval processes to ensure adherence to regulations and guidelines. You would have a direct impact on the success of this company by: Preparing documents such as drug applications, protocols, amendments, progress reports, as well as preparing information for submission to applicable agencies and review boards.
NewEquipment Engineer (Cell) QcellsEquipment Engineer (Cell)Cartersville, GAEquipment Engineers mainly manage the maintenance and operation of automated, laser, metallization, sorter, thermal, vacuum, or wet etching equipment systems within the production facility. Set equipment specifications with optimized production conditions and create utility specification that includes raw material usage and hookup description.
International Regulatory Specialist Globus Medical IncInternational Regulatory SpecialistPAEssential Functions: Work in conjunction with other departments to develop submissions; Partner with Product Development, Quality Assurance, and management to prepare and review international regulatory submissions including CE technical files and design dossiers, and other international filings, to obtain marketing clearance; Obtain timely marketing clearance for all products in parallel with US submissions; Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as they pertain to international regulations; Coordinate, review and submit product labeling for marketing outside the U.S. Review design changes and technical files for updates to documentation; Prepare and file certificates to foreign governments with FDA; Develop relevant regulatory SOPs as necessary; and. Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products.
NewRegulatory Specialist - Wireless Industry Macpower Digital Assets Edge Private LimitedRegulatory Specialist - Wireless IndustryCanonsburg, PARemote$30–$34 / hourJob Summary: Prepare and file FCC and FAA applications for tower erection, modifications, and antenna installations. Responsibilities: Review scopes of work for modifications, collocations, and new easements to determine regulatory needs.
Regulatory Labeling Specialist J.M. Huber CorpRegulatory Labeling SpecialistHanover, PAThe Regulatory Labeling Specialist interacts regularly with the marketing team to ensure brand consistency, with the technical team to make sure that the label is accurate, and with the regulatory team to ensure label text is regionally compliant. The Specialist must be comfortable managing multiple label requests in parallel, quickly resolving issues, obtaining printer proofs, and maintaining strong working relationships with external vendors and internal stakeholders.
Air Quality and Regulatory Compliance Specialist PennEnergy Resources LLC.Air Quality and Regulatory Compliance SpecialistCranberry Township, PAFull timeMaintain accurate and current air quality compliance records for various initiatives: leak detection and repair (LDAR) program, the Directed Inspection and Preventative Maintenance Program (DI/PM), emissions inventory reporting records, state/federal compliance reports and others as needed. The potential for work in areas containing outdoor weather conditions, including wet, humid, cold, heat, loud noise, vibrations, gases, fumes, mists, dust, and odors if onsite visitation is needed.
RN, Regulatory Compliance Quality Specialist Thomas Jefferson UniversityRN, Regulatory Compliance Quality SpecialistPhiladelphia, PAThomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research.
Clinical Pharmacy Specialist Regulatory--HUP Penn MedicineClinical Pharmacy Specialist Regulatory--HUPPhiladelphia, PAThe CPS-R will also participate in the design and implementation of management controls and practices to ensure that all business units are compliant with Federal, State and local rules and regulations, including, but not limited to, FMCSA, CA BIT, PHMSA, CSA, OSHA, FSMA, AIB and IFTA. Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine.
Senior Specialist, Regulatory Oversight Management The Bank of New York Mellon CorpSenior Specialist, Regulatory Oversight ManagementPittsburgh, PAIn this role, you'll make an impact in the following ways: Supports management in the day-to-day efforts related to first line of defense regulatory oversight management with laws, rules, regulations, and related policies. Every day, our teams harness cutting-edge AI and breakthrough technologies to collaborate with clients, driving transformative solutions that redefine industries and uplift communities worldwide.
Specialist Actuarial Pricing, Regulatory AXA SASpecialist Actuarial Pricing, RegulatoryEXTON, PA$89,400–$148,600 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business property, casualty, professional, financial lines and specialty. AXA Hearts in Action: We have established volunteering and charitable giving programs to help colleagues support causes that matter most to them, known as AXA XL's "Hearts in Action" programs.
Senior Regulatory Oversight Specialist Vanguard GroupSenior Regulatory Oversight SpecialistMalvern, PAAssists and supports the Registered Principals Responsible (RPR) with complex internal audits, risk assessments, OSJ inspections, FINRA and SEC inspections, and regulator requests for Written Supervisory Procedures (WSPs). The oversight expands across both crew and direct leader duties to ensure compliance with the policy and procedures set forth to support Personal Investor's evolving product and service offerings and evolving regulatory landscape.
AVP, Senior Regulatory & Governance Risk Management Specialist Everest Group LtdAVP, Senior Regulatory & Governance Risk Management SpecialistPhiladelphia, PA$175,000–$215,000 / yearThe role acts as a senior subject matter expert on regulatory risk governance, supporting engagement with regulators and internal stakeholders, and contributing to the ongoing development and embedding of the Enterprise Risk Management (ERM) framework with a focus on non-financial risks. We are a global team focused on disciplined capital allocation and long-term value creation for all stakeholders, who care deeply about our impact on communities and the wider world.
Regulatory Communications Specialist Vanguard GroupRegulatory Communications SpecialistMalvern, PACreate communications that enable and equip client-facing crew to discuss regulatory matters with clients with confidence (e.g., send text, positioning, discussion guides, FAQs, videos, etc.). The role supports the Workplace Solutions business which provides investment solutions and services to meet the needs of employers offering company-sponsored retirement plans and to improve the financial well-being of millions of investors.
Associate Director, Regulatory University of PennsylvaniaAssociate Director, RegulatoryPhiladelphia, PA$105,500–$130,000 / yearThe Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania’s Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will assist the Director with facilitating and tracking the flow of new research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process will track, analyze and report to senior leadership department-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineUpper Gwynedd, PA$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.
Product Stewardship and Regulatory Affairs Sp AGC IncProduct Stewardship and Regulatory Affairs SpExton, PAEssential Functions: Supports new product registrations for Americas region, e.g., TSCA PMN/LVE/Polymer Exemptions, and Canadian DSL/NDSL notifications in close collaboration with R&D and global product stewardship teams. The position is part of a global highly interactive, diverse, and supportive team and will manage product stewardship activities to enable sales of new products and maintain the right to operate with existing products.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesNorth Wales, PA$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.
Senior Director, Regulatory Affairs ICON PlcSenior Director, Regulatory AffairsBlue Bell, PAAs a Senior Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions. Key responsibilities include: Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.
Program Manager, Regulatory Affairs Olympus CorpProgram Manager, Regulatory AffairsPAResponsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison Merck & Co IncSr. Principal Scientist (Sr. Director) - Regulatory LiaisonNorth Wales, PA$190,800–$300,300 / yearRequired Skills: Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, 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.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyCollegeville, PA$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 of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationRadnor, PA$157,500–$262,500 / yearExperience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsEXTON, PA$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsCollegeville, PA$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.
Regulatory Operations Manager Actalent IncRegulatory Operations ManagerHarleysville, PA$105,000–$115,000 / yearThe position also manages regulatory and compliance support for customers, collaborates closely with internal stakeholders to maintain and improve the quality system, and proactively monitors the regulatory landscape to identify and address compliance risks. Establish and maintain a comprehensive regulatory operations program that supports cosmetics under MoCRA, OTC pharmaceutical products, medical devices, and other regulated product categories in all markets served.
NewPrincipal, Regulatory Affairs Intelligence West Pharmaceutical Services IncPrincipal, Regulatory Affairs IntelligenceExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role requires deep expertise in global regulatory frameworks, with a specialized focus on containment systems (i.e., primary packaging), pharmaceutical manufacturing and handling, and regulatory requirements applicable to drugs and drug constituents of combination products.