Hybrid International Tax Manager JobotHybrid International Tax ManagerPhiladelphia, PA$160,000–$200,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Our new team member will be responsible for managing various aspects of international taxation, including but not limited to, tax compliance, tax planning, and tax accounting.
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.
NewAP Manager Vaco LLCAP ManagerAbington, PA$85,000–$110,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
Sr Manager, Market Access - US - Medical Device JouléSr Manager, Market Access - US - Medical DeviceBlue Bell, PARemote$145,000–$180,000 / yearLeads all aspects of Market Access actions in North AmericaWorks cross-functionally with Clinical Affairs, Regulatory Affairs, Governmental Affairs, Commercial, Medical Affairs and Regional Marketing colleagues in North America. The ideal candidate has owned the market access role during a product launch in the US market and has worked in close collaboration with other business functions (medical affairs, governmental affairs, legal, regulatory, marketing and sales) in prior roles.
NewGeneral Manager LUV Car WashGeneral ManagerExton, PA$55,000–$65,000 / yearThe General Manager (GM) is responsible for all site operations including recruiting of staff, site safety, facilities management, customer service, driving sales, site compliance and the development of the car wash team. Partner with Facilities to ensure all equipment is properly maintained, safely operated and maintenance requests are fulfilled in a timely manner to minimize site downtime.
NewCitizens Branch Manager CitizensCitizens Branch ManagerPhiladelphia, PALeadership experience, with proven ability to coach and develop to drive sales excellence, ensure the delivery of world-class customer service, and operational integrity in a high-volume branch environment. Successful candidate must meet and comply with all requirements set forth in the SAFE Act, including, but not limited to successful completion of the required background checks and obtaining a unique identifier from the NMLS.
NewExecutive Sales Manager - Aesthetics Acclaro CorporationExecutive Sales Manager - AestheticsPhiladelphia, PAYou will develop and execute territory and account strategies, manage complex and consultative sales cycles for high-value capital equipment, and collaborate closely with marketing, clinical, and service teams to deliver comprehensive solutions. Committed to continuous innovations, Acclaro Corporation aspires to lead the energy-based medical device industry by aligning the latest technologies with market demand to deliver life-changing results for healthier and happier life for all men and women in the world.
NewManufacturing Technology Manager Ecolab Inc.Manufacturing Technology ManagerPhiladelphia, PA$133,700–$200,600 / yearTheir knowledge of ion exchange resin products and production processes will be applied to our G-Street production facility to drive continuous improvement in quality, batch to batch consistency, productivity and customer satisfaction. Reporting to the Site Director, this role will need to be working closely with Production, Quality, Engineering and RD&E to understand business priorities, agree goals and deliver embedded process improvements within a 24/7 manufacturing operation.
Project Manager: Civil Construction - Williamstown, NJ Page GroupProject Manager: Civil Construction - Williamstown, NJWilliamstown, NJ$120,000–$150,000 / yearFull timeA successful Project Manager: Civil Construction should have: Proven experience in civil construction project management within the property industry. We are seeking a Project Manager: Civil Construction to oversee and manage construction projects from inception to completion in Williamstown, NJ.
Project Manager / Estimator Page GroupProject Manager / EstimatorGloucester City, NJ$130,000–$170,000 / yearFull timeWe are seeking an experienced Marine Construction Project Manager to lead and oversee marine and waterfront construction projects from pre-construction through completion. Our client is a leading marine construction firm specializing in waterfront infrastructure, including docks, piers, bulkheads, dredging, and coastal protection projects.
NewAssistant Branch Manager Pro Truck Herc Rentals IncAssistant Branch Manager Pro TruckPhiladelphia, PA$75,000–$85,000 / yearFounded in 1965, Herc Rentals is one of the leading equipment rental suppliers in North America with 2025 total revenues reaching approximately $4.4 billion. Herc Rentals serves customers through approximately 609 locations and has about 9,700 employees in North America as of March 31, 2026.
NewAccount Manager Shields Facilities Maintenance LLCAccount ManagerMaple Shade, NJ$50,000–$60,000 / yearShields Facilities Maintenance is a national, world-class vendor management company boasting an extensive network of vendors, customized customer relationship management software, and an operations team who possess expertise and customer service skills that are second to none in the industry. Shields Facilities Management, LLC, (SFM) is seeking highly motivated applicants for an Account Manager position working with our Operations Team to manage the delivery of services.
NewExecutive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz PharmaceuticalsExecutive Director, US Medical Affairs, Oncology Solid Tumor LeadPhiladelphia, PARemote$304,000–$456,000 / yearThis role will be the strategic partner for the Oncology Solid Tumor Commercial Lead and collaborate extensively on the design and execution of deployment of field colleagues in support of the therapeutic space, including the design and execution of account-level cross-functional collaboration, quality engagement, field and payer value, evidence strategy and execution, and serve as an SME in compliant medical design. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewDirector, Clinical Development, Neuroscience Jazz PharmaceuticalsDirector, Clinical Development, NeurosciencePhiladelphia, PARemote$196,000–$294,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of clinical trials and programs.
NewSenior Director, Oncology Pharmacology Jazz PharmaceuticalsSenior Director, Oncology PharmacologyPhiladelphia, PARemote$232,000–$348,000 / yearPrimary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.
NewDirector, Business Development Larimar TherapeuticsDirector, Business DevelopmentPhiladelphia, PAThe successful candidate will have a deep understanding of business and market dynamics, transactions and partnerships, a track record of developing and executing successful corporate strategies, robust understanding of finance, and the ability to work collaboratively with cross-functional teams. Foster collaborative and supportive cross-functional working relationships, including engaging the senior leadership team in the development and prioritization of long-term strategies and acting as a thought partner with the business to make effective and timely decisions .
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.
NewRegulatory 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.
Mgr, Product Stewardship & Regulatory Affairs AGC IncMgr, Product Stewardship & Regulatory AffairsExton, PAThis role operates within a global CSR and product stewardship organization and is critical to enabling new product commercialization, maintaining regulatory compliance for existing products, and supporting long-term business growth. • Supports and progressively leads new product registrations in the Americas, including TSCA PMNs, LVEs, Polymer Exemptions, Canadian DSL/NDSL notifications, and TSCA Sections 8(c)/8(e) evaluations.
Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical Services IncPrincipal Regulatory Affairs Project Manager, Medical DevicesExton, 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. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
Group Manager, Regulatory Affairs Globus Medical, Inc.Group Manager, Regulatory AffairsAudubon, PAThe Group Manager, Regulatory Affairs oversees the preparation and submission of regulatory premarket applications, and gains 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. + Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
Manager - North American Solution Consulting - Regulatory Veeva Systems IncManager - North American Solution Consulting - RegulatoryPhiladelphia, PA$110,000–$175,000 / yearStrategic Deal Support: Provide oversight and hands-on support for key opportunities within the Regulatory space ensuring the team effectively communicates the value of Veevas unified RIM platform. As the Manager of Solution Consulting for our Regulatory team you will empower a high-performing group of experts who bridge the gap between complex Regulatory challenges and Vault RIM solutions.
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.
NewAssociate Manager, Regulatory & Scientific Affairs International Flavors & FragrancesAssociate Manager, Regulatory & Scientific AffairsWilmington, DEli>Prepare, review, and submit regulatory dossiers and filings, including Generally Recognized as Safe (GRAS) notices, New Dietary Ingredient Notifications (NDINs), Product License Applications (PLAs), Master Files, and Chemistry, Manufacturing, and Controls (CMC) documentation. This role is part of global regulatory focus teams and partners closely with R&D, Quality, Commercial, Marketing, and Legal stakeholders to ensure regulatory compliance while enabling product development, manufacturing, and commercialization.
Quality Assurance and Regulatory Manager The Food Source InternationalQuality Assurance and Regulatory ManagerExton, PennsylvaniaThe ideal candidate is a strategic leader with deep regulatory expertise, strong audit experience, and a proven ability to build high-performing quality teams. The Quality Assurance & Regulatory Manager is responsible for leading corporate-level quality, food safety, and regulatory compliance programs across TFSI and its co-manufacturing partners.
Manager, Regulatory Affairs Globus MedicalManager, Regulatory AffairsAudubon, PennsylvaniaGuides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing. Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement.
Sr. Manager, Technical Regulatory Compliance Johnson & JohnsonSr. Manager, Technical Regulatory ComplianceWest Chester, PAThe position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Quality Regulatory, Manager Trinity HealthQuality Regulatory, ManagerDarby, PAConsistently recognized for clinical excellence, Mercy Fitzgerald is proud of our many quality achievements such as: Blue Distinction Center for Cardiac Care, Bariatric Surgery Center of Excellence, Achievement Awards from the American Heart/Stroke Associations and Certified Primary Stroke Center. Engages in performance improvement projects to support Mercy Fitzgerald priorities in fulfilling the vision and mission that lead to regulatory compliance, high quality organization, patient safety, and operational excellence.
NewSenior Manager, North America Regulatory Liaison J&J Family of CompaniesSenior Manager, North America Regulatory LiaisonAmbler, PARequired Skills: Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility . Preferred Skills: Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility .
Senior Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterRadnor, PAVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerPA$144,600–$265,100 / yearCandidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.
Regulatory Reporting Manager JPMorgan Chase & CoRegulatory Reporting ManagerNewark, DEOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.
Legal & Regulatory Change Management Control Manager - Senior Associate JPMorgan Chase & CoLegal & Regulatory Change Management Control Manager - Senior AssociateNewark, DEOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.
Regulatory Project Manager ICON PlcRegulatory Project ManagerBlue Bell, PARepresents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client's needs and regulatory team goals. The Regulatory Project Manager collaborates with regional and global cross functional teams to plan, prepare and deliver compliant regulatory submissions, providing support.
Manager, Financial Statement and Regulatory Reporting The Citco Group LtdManager, Financial Statement and Regulatory ReportingMalvern, PAAbout You: 4-6 years of experience in an Accounting Firm, Hedge Fund, Private Equity Administrator, Audit, or other financial institution where you have gained financial products knowledge. From working exclusively with hedge funds to serving all alternatives, corporations and private clients, our organization has grown immensely across asset classes and geographies.
Regulatory Governance Control Manager - Associate JPMorgan Chase & CoRegulatory Governance Control Manager - AssociateNewark, DEAs a Control Manager within the Wholesale Lending Services Controls Governance team, you partner with Firmwide Program teams to assess program requirements and operational adherence, and guide business stakeholders to ensure a robust control framework that mitigates risk across all sub-lines of business. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
Regulatory Governance Control Manager - Senior Associate JPMorgan Chase & CoRegulatory Governance Control Manager - Senior AssociateNewark, DEOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. Required Qualifications, Capabilities, and Skills: Bachelor's degree and at least five years of Banking and Financial Services experience across controls, audit, quality assurance, operational risk management, project management, governance, metrics reporting, or compliance.
Regulatory Compliance Senior Program Manager Qurate Retail Group, Inc.Regulatory Compliance Senior Program ManagerPAThe Regulatory Compliance Senior Program Manages cross-functional initiatives that strengthen regulatory compliance through scalable, sustainable processes, while driving collaboration, process improvement, and measurable business results. Product-focused technical experience, including working with partner and third-party laboratories, interpreting product testing reports, and identifying the appropriate testing requirements for products.
Regulatory Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerPA$82,600–$162,800 / yearManage end to end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring compliance with applicable regulatory requirements across various regulators such as SEC, CFTC, BEA, NFA, Treasury. We "embed continuous advantage" through domain, industry, technology and transformation skills to perform client business functions that manage risk and deliver value-added outcomes, all while driving predictable long-term revenue, profitability, and growth.
NewProject Manager- Regulatory at Penn Medicine Penn MedicineProject Manager- Regulatory at Penn MedicinePhiladelphia, PAProvide demonstrations, presentations and formal classes as necessary; Provide periodic written status reports to the Director and Associate Director of Regulatory and Project Committees showing status compared to the work plan, issues, risk, and assignments/plans for resolution, resolved issues, problem log and status, upcoming major project situations, and adherence to project budgeted resources; Build and maintain databases and dashboards that support the work of the Regulatory Director as required. collates and assembles reports and documents as required by Director of Regulator; Draft and edit, PowerPoint presentations, scripts, talking points, leadership messages, and other communications as relates to both internal and external outreach; Ensure messages are appropriately written for targeted audiences.
Ent Amb Regulatory Prog Mgr Thomas Jefferson UniversityEnt Amb Regulatory Prog MgrPhiladelphia, PAJefferson 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.
Program Manager, Regulatory Operations Financial Industry Regulatory Authority IncProgram Manager, Regulatory OperationsPhiladelphia, PAFINRA employees are required to disclose to FINRA all brokerage accounts that they maintain, and those in which they control trading or have a financial interest (including any trust account of which they are a trustee or beneficiary and all accounts of a spouse, domestic partner or minor child who lives with the employee) and to authorize their broker-dealers to provide FINRA with duplicate statements for all of those accounts. Additional insurance includes basic life, accidental death and dismemberment, supplemental life, spouse/domestic partner and dependent life, and spouse/domestic partner and dependent accidental death and dismemberment, short- and long-term disability, long-term care, business travel accident, disability and legal.
Financial & Regulatory Reporting Associate Manager U.S. BancorpFinancial & Regulatory Reporting Associate ManagerPhiladelphia, PA$98,345–$115,700 / yearIn addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures. Reviews the accounting and financial statement information provided for audit and tax reviews, documentation and set-up of the accounting principles for unusual investment types, and set-up/processing of complex expense and incentive fee calculations and reconciliation items.
Financial & Regulatory Reporting Manager U.S. BancorpFinancial & Regulatory Reporting ManagerPhiladelphia, PA$98,345–$115,700 / yearIn addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures. Ownership over the review and delivery of monthly / quarterly unaudited financial statements for various hedge funds and private equity funds to client(s).
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.
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.
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 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.
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.