NewDirector, Regulatory Affairs, Ex-US Larimar TherapeuticsDirector, Regulatory Affairs, Ex-USPhiladelphia, PAPrepare 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. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
NewGRA CMC Specialist CSL BehringGRA CMC SpecialistKing of Prussia, PASupport the collaboration with CSL’s Corporate & External Affairs organization to support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
NewProperty Adjuster Specialist - Field USAAProperty Adjuster Specialist - FieldPhiladelphia, PARemote$69,920–$133,620 / yearProactively manages assigned claims caseload comprised of complex damages that require commensurate knowledge and understanding of claims coverage including potential legal liability. 2 years of relevant property claims adjusting experience of moderate complexity losses that includes writing estimates, involving dwelling and structural damages.
NewSenior Field Supply Chain Specialist - Contract TalentBurst, Inc.Senior Field Supply Chain Specialist - ContractWilmington, DE$37.93–$59.85 / hourThe role focuses on executing Business Integration Testing (BIT) and User Acceptance Testing (UAT) by generating and validating label outputs across SAP environments. Client is seeking an experienced SAP GLM Specialist within the Supply Chain Data organization to support Global Label Management and SAP EHS activities.
NewRegional Nurse Education Specialist - RN Fltr Philadelphia PARegional Nurse Education Specialist - RNPhiladelphia, PA$125,000–$140,000Program Delivery: Coordinate and deliver comprehensive clinical education programs, including new employee orientation, annual competencies, and targeted skills training (e.g., wound care, infection control, IV therapy, cardiac monitoring). *Collaborative Leadership: Collaborate with the Market Clinical Advisor, Directors of Nursing, and Interdisciplinary Teams, and mentor new clinical leaders to promote consistency in clinical operations and care delivery.
NewProduct Support Specialist CAIProduct Support SpecialistNewark, DE$18–$20This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment. We are looking for a Product Support Specialist to provide data entry of Medicaid Renewal applications, ensuring a quality application is entered into the eligibility system.
NewClassroom Intervention Specialist Abraxas Youth & Family ServicesClassroom Intervention SpecialistMorgantown, PA$0–$22By exploring geographical program expansion and focusing on quality outcome measures to create cost savings that result in reinvestment into the organizations stakeholders through capacity creation and employee compensation betterment. About Company:Apis Services, Inc. (a wholly owned subsidiary of Inperium, Inc.) provides a progressive platform for delivering Shared Services to Inperium and its Constellation of affiliate companies.
NewPrincipal 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).
AP Specialist Page GroupAP SpecialistMedia, PA$25–$27 / hourFull timeTake full ownership of the end-to-end Accounts Payable function, including invoice processing, payment execution, and vendor management. This position plays a key role in stabilizing AP operations, partnering closely with leadership, and driving process improvements through automation tools.
NewSr. Director, Global Labeling Strategy CSL BehringSr. Director, Global Labeling StrategyKing of Prussia, PADue to the global nature of the position, the Head of Global Labeling Strategy engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development, Medical Affairs and Market Access to ensure business critical objectives are met and scientific, regulatory compliant labeling is provided to Health Care Professionals. Works closely with the TA Heads, GRA GRS to maintain an effective, globally-minded, Global Regulatory Affairs and Safety organization that is focused on utilizing creative problem-solving skills, can clearly articulate the science / regulatory perspective to stakeholders, and contributes to the overall TA Strategy for each TA.
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.
Specialist 3 - Regulatory Affairs Sunrise Systems IncSpecialist 3 - Regulatory AffairsWest Chester, PAFor those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
Regulatory Affairs Specialist, Global Quaker Chemical CorpRegulatory Affairs Specialist, GlobalPASupport 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.
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.
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.
Specialist 3 - Regulatory Affairs The Fountain Group LLCSpecialist 3 - Regulatory AffairsWest Chester, PA$52–$55 / hourUnderstand, 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.
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.
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).
North American Regulatory Affairs Specialist International Flavors & Fragrances IncNorth American Regulatory Affairs SpecialistWilmington, DEHealth & Biosciences: Channeling our passion for nature and bioscience into sustainable, life-enhancing technologies that power innovative solutions across healthcare, food, consumer and industrial markets. Prepare and contribute to regulatory submissions, including Generally Recognized as Safe (GRAS), Association of American Feed Control Officials (AAFCO), and Canadian feed (CFIA) approvals.
North America Product Stewardship & Regulatory Specialist DuPont de Nemours IncNorth America Product Stewardship & Regulatory SpecialistWilmington, DEWe're looking for a North America Product Stewardship & Regulatory Specialist to play a critical role in ensuring our products are safe, compliant, and positioned for sustainable growth across their lifecycle. Partner with global Tyvek product stewardship leaders and cross-functional teams (R&D, manufacturing, supply chain, marketing, legal, and sustainability).
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.
Specialist 3 - Regulatory Affairs eTeam Inc.Specialist 3 - Regulatory AffairsWest Chester, PA$53–$57.72 / hourUnderstand, 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.
Specialist 3 - Regulatory Affairs Ampcus IncorporatedSpecialist 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.
Specialist 3 - Regulatory Affairs Artech LLCSpecialist 3 - Regulatory AffairsWest Chester, PA$55–$57.30 / hourUnderstand, 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 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 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. Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
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.
Regulatory Affairs Specialist IDE GroupRegulatory Affairs SpecialistPhiladelphia, PASearch for: MenuMedTech 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 ChallengeWinners 2025Opportunity & PrizesChallengersYour MotivationJudgesInterview SeriesOur ImpactContact. Search for:
NewClinical Research Regulatory Specialist - Profound Autism Research Study and Orphan Disease Center Children's Hospital of PhiladelphiaClinical Research Regulatory Specialist - Profound Autism Research Study and Orphan Disease CenterPhiladelphia, PA$76,100–$97,000 / yearThis position is responsible to assist with the preparation, review, and submission of all protocols, amendments, informed consent documents, annual This position is responsible for assisting with the preparation, review, and submission of all protocols, amendments, informed consent documents, annual reviews and safety reports to the IRB for a large-scale longitudinal research project spanning multiple departments, including Developmental Behavioral Pediatrics, Neurology, Genetics, and the Center for Autism Research at Children's Hospital of Philadelphia. This ideal candidate must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.
Regulatory Compliance Specialist Evolution ABRegulatory Compliance SpecialistPhiladelphia, PA$65,000–$75,000 / yearOur live services, which allow licensees' players on desktop, tablet and smartphone to play Live Casino games at real tables and with real dealers, have won multiple industry awards, including 'Live Casino Supplier of the Year' at the EGR B2B Awards for eleven consecutive years and 'Casino Content Provider of the Year' in the 2019 EGR North America Awards. Evolution is the world´s leading provider of video-streamed Live Casino solutions and Slots, delivering best-in-class 'as real as it gets' live dealer gaming to our licensees including many of the world´s best known gaming brands.
Financial Crime Risk Specialist - Regulatory Response & Audit Oversight The Toronto-Dominion BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightWilmington, DE$91,000–$145,600 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Employee/Team Accountabilities: Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
NewPermitting & Regulatory Compliance Specialist II Core States GroupPermitting & Regulatory Compliance Specialist IIPARemoteHEALTHCARE - Competitive health benefits including HSA with employer contribution, life insurance options, and supplemental coverage options, giving you the flexibility to select the coverage that best fits your needs and lifestyle. Core States Group designs, builds, and manages programs and projects across North America and has been recognized on top lists throughout the architecture, engineering, and construction (A/E/C) industry.
NewClinical 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.
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.
Fund Financial & Regulatory Reporting Analyst, Specialist Vanguard GroupFund Financial & Regulatory Reporting Analyst, SpecialistMalvern, PAp>Vanguard has implemented a hybrid working model for the majority of our crew members, designed to capture the benefits of enhanced flexibility while enabling in-person learning, collaboration, and connection. Keeps current on global regulatory changes that will affect fund financial statement disclosures, and works with third party service providers and auditors to develop and implement changes.
NewRegulatory Communications Specialist The Vanguard GroupRegulatory Communications SpecialistMalvern, PennsylvaniaCreate 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.
Regulatory Affairs Manager Regulatory Reporting Essity ABRegulatory Affairs Manager Regulatory ReportingPhiladelphia, PAEssity's Digital Transformation & Business Enablement team is looking for an experienced Regulatory Affairs Manager focused on North American regulatory reporting across all business units related to various topics including packaging regulations, chemical regulations, etc. As an employee at Essity, you will belong to a team where you feel valued, are safe, supported to grow and challenged to generate business results in a friendly and open atmosphere.
NewAssociate 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.
Director, Regulatory Affairs ICON PlcDirector, Regulatory AffairsBlue Bell, PAAs a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients.
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.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsWilmington, DEDesirable Skills/Experience: • Advanced degree in life sciences, pharmacy, law, or a related discipline • 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters • Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms • Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns • Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders • Demonstrated influence at senior levels to shape departmental practices and operational plans • People leadership experience with a track record of coaching and building high-performing teams. Essential Skills/Experience: • Bachelor's degree in science • 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review • 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences • Knowledge of the drug development and labeling processes.
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.
Associate Director, International Regulatory Affairs Incyte CorpAssociate Director, International Regulatory AffairsWilmington, DEJob Summary Primary function The Associate Director International Regulatory Affairs works in collaboration with International Regulatory Affairs Lead to develop regulatory strategies with multi-functional teams and partners and ensures that International Regulatory Requirements for assigned products are complete. Provide appropriate regulatory strategies to support submission of marketing and life-cycle applications may also include support of clinical trial applicationsexpanded access programs in International Markets Provides regulatory support to inter-departmental project teams.
NewSenior Manager, Regulatory Affairs West Pharmaceutical ServicesSenior Manager, 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. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.
Regulatory Affairs Manager CMC CSL Behring LLCRegulatory Affairs Manager CMCKing of Prussia, PAThat collaboration shapes the high-quality, compliant CMC regulatory submissions you'll manage end-to-end- new marketing applications, clinical trial applications, variations, supplements, periodic compliance reports, and renewals - each one needing to be technically sound and built to withstand regulatory scrutiny. As a Regulatory Affairs Manager CMC you will drive regulatory CMC strategy for your assigned products, spanning both development and commercial stages, working closely with colleagues across Global Regulatory Affairs CMC, R&D, Quality, and Global Operations.
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.