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.
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.
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 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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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 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.
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.
Vice President, Regulatory Affairs Cabaletta Bio IncVice President, Regulatory AffairsPhiladelphia, PARegulatory Submissions & Compliance Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. Team Leadership Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy.
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 Program Coordinator Temple UniversityRegulatory Program CoordinatorPhiladelphia, Pennsylvania$50,000–$55,000The Regulatory Program Coordinator, under the supervision of the Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department. Temple University's Lewis Katz School of Medicine's Pulm/Critical Care/SleepMed Department is searching for a Regulatory Program Coordinator to join our team.
Senior Counsel, Compliance, Regulatory & Quality West Pharmaceutical Services IncSenior Counsel, Compliance, Regulatory & QualityExton, 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. Reporting to and working in close partnership with our General Counsel and Chief Compliance Officer, this role is a key legal advisor to the Company in the area of overall Compliance, including privacy, and helps to oversee and manage West's global compliance program.
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.
Vice President, Regulatory Affairs, CMC Madrigal Pharmaceuticals IncVice President, Regulatory Affairs, CMCConshohocken, PA$315,000–$386,000 / yearPlease know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Director, Regulatory Affairs - CMC ICON PlcDirector, Regulatory Affairs - CMCBlue Bell, PARemoteWe are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience. As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.
Regulatory Affairs Supervisor (Pharmaceutical Distribution Ops / Supply Chain) Valley Forge PharmaRegulatory Affairs Supervisor (Pharmaceutical Distribution Ops / Supply Chain)Malvern, PA$50,000p>EXPERIENCE: -Must have at least 2 years of relevant supervisory or managerial experience in pharmaceutical distribution, wholesale distribution, or pharmacy operations, and the experience must be recent (at least one year within the last three years is stipulated for California's DR requirements). Other responsibilities include comparing identifying information, counts, weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices orders, and other records.
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.
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.
Sr Regulatory Program Coord Temple UniversitySr Regulatory Program CoordPhiladelphia, PAp>'','''','''',''Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science Hall'',''Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science Hall'','''','''',''Staff'',''Staff'',''Full-time'',''Full-time'',''Day Job'',''Day Job'',''Regular'',''Regular'',''false'',''519008'',''519008'',''true'',''519008'',''false'',''Submission for the position: Sr Regulatory Program Coord - (Job Number: 26000884)'',''false'',''519008'',''false'',''true''. Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department.
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.
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.
Principal Specialist, Regulatory Affairs West Pharmaceutical Services IncPrincipal Specialist, Regulatory AffairsExton, PAp>Preferred 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).
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.
Senior Director, Global Quality & Regulatory - Exton, PA DSM Nutritional Products Asia Pacific Pte LtdSenior Director, Global Quality & Regulatory - Exton, PAExton, PA$157,200–$225,000 / yearDeep knowledge of quality management systems and regulatory frameworks applicable to medical devices and related products for a Class III medical device operation (21CFR 820, ISO 9001, 13485, 14001, 45000); experience with clean room theory and operation is a plus. This member of the Global Leadership Team serves as the global head of Quality & Regulatory for Biomedical and is accountable for setting strategy, driving execution, and fostering a culture of compliance, continuous improvement, and operational excellence across all sites and functions.
Regulatory Associate Globus Medical, Inc.Regulatory AssociateAudubon, PAThe Regulatory Affairs Associate assists in 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. + Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting.
Senior Director, Regulatory Affairs REMS Program Cytokinetics IncSenior Director, Regulatory Affairs REMS ProgramRadnor, PA$263,880–$307,860 / yearReporting to the Executive Director, Regulatory Affairs, the Senior Director, Regulatory Affairs, REMS Program is responsible for leading regulatory strategy and execution related to Risk Evaluation and Mitigation Strategy (REMS) and providing regulatory compliance oversight for REMS. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.