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.
NewDialysis Clinical Manager Registered Nurse - RN Fresenius Medical CareDialysis Clinical Manager Registered Nurse - RNPrinceton, NJ$85,000–$143,000 / yearFacilitate timely workup of patients for access management, dialysis services, patient education, hospitalizations, and kidney transplantation as appropriate, and ensures coordination of care with the multidisciplinary renal team. Demonstrated leadership competencies and skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management, and decision making.
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.
NewEnvironmental, Health & Safety, and Human Resources Manager SugarightEnvironmental, Health & Safety, and Human Resources ManagerFairless Hills, PA$90,000–$115,000 / yearAssist in managing the relationship with the company employer medical provider, including the coordination and management of work-related injuries and the workers compensation program, and pre-employment physical evaluations and drug screening. Audits facilities or processes to identify weaknesses or risks and proactively develops and implements corrective actions; ensures appropriate investigation of and response to accidents or injuries.
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.
Senior Operations Manager (Supply Chain/Logistics) PenskeSenior Operations Manager (Supply Chain/Logistics)Langhorne, PAFull timeInteract daily with our local customer to ensure we understand existing and emerging customer needs, Utilize team to identify operational improvements in areas such as route optimization, carrier selection, backhauls, trailer loading, inventory accuracy and warehouse operations, Collaborate with other Penske sites to share best practices, leverage resources/assets, etc. -Develop and execute annual financial and operating plan, Manage the operation with integrity to meet or exceed the Business Plan targets, Identifies issues with the operating metrics and P&L and responds accordingly, Ensure customer billings and associate payroll are prepared timely and accurately, the payables and intercompany charges are valid and correct, and all other activities are accurately reflected in the P&L.
Child Care Manager Chesterbrook AcademyChild Care ManagerCollegeville, PA$68,000–$76,000Since opening its doors in 2009, Chesterbrook Academy Collegeville has been committed to providing exceptional early childhood education to families throughout Schwenksville, Pottstown, Douglassville, Souderton, Harleysville, Norristown, and Gilbertsville through a NAEYC-accredited program grounded in academic excellence and genuine care. If you're an experienced early childhood leader who is passionate about developing educators, building strong school communities, and creating exceptional experiences for children and families, we encourage you to apply.
Preschool Manager Chesterbrook AcademyPreschool ManagerCollegeville, PA$68,000–$76,000Since opening its doors in 2009, Chesterbrook Academy Collegeville has been committed to providing exceptional early childhood education to families throughout Schwenksville, Pottstown, Douglassville, Souderton, Harleysville, Norristown, and Gilbertsville through a NAEYC-accredited program grounded in academic excellence and genuine care. If you're an experienced early childhood leader who is passionate about developing educators, building strong school communities, and creating exceptional experiences for children and families, we encourage you to apply.
Childcare Manager Chesterbrook AcademyChildcare ManagerCollegeville, PA$68,000–$76,000Since opening its doors in 2009, Chesterbrook Academy Collegeville has been committed to providing exceptional early childhood education to families throughout Schwenksville, Pottstown, Douglassville, Souderton, Harleysville, Norristown, and Gilbertsville through a NAEYC-accredited program grounded in academic excellence and genuine care. If you're an experienced early childhood leader who is passionate about developing educators, building strong school communities, and creating exceptional experiences for children and families, we encourage you to apply.
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.
Inpatient Registered Nurse (RN) or Social Worker (MSW) Care Manager, Full Time, Grandview Campus St. Luke's Health Network, Inc.Inpatient Registered Nurse (RN) or Social Worker (MSW) Care Manager, Full Time, Grandview CampusSellersville, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Registered Nurse or Social Worker Care Manager is responsible for coordinating the complex discharge planning needs of patients, as well as to provide supportive counseling, psycho-social assessment, and interventions for designated patient populations across the continuum of care.
Senior Manager, Practice Operations - Pulmonary St. Luke's Health Network, Inc.Senior Manager, Practice Operations - PulmonarySellersville, PAFull timeMaintains strong collaboration and connectivity with Access Center operations and centralized functions (e.g., POD, Capacity Management, etc.) to enable seamless operations and optimal patient/employee experiences (e.g., transfers, triage protocols, template changes, huddles, POD/practice connectivity, etc.). Ensures operational readiness for clinical and administrative operations (e.g., developing employee schedules; maintaining supply inventory, office equipment and furnishings, cleanliness; facilitating daily huddles; updating time management systems; maintaining Point of Care licensing, etc.).
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.
Case Manager per diem for ARC St. Luke's Health Network, Inc.Case Manager per diem for ARCSellersville, PAPart timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. This includes assessing, planning, implementing, coordinating, and evaluating health and community related services to meet a patient’s physical, psychosocial, vocational, and health needs in a cost effective, outcomes-oriented, and timely manner.
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 .
Data Center Resiliency Manager EclaroData Center Resiliency ManagerLawrenceville, NJ$68.52–$72.68 / hourFull timeManage small and large scope walk-through and simulation-type disaster recovery exercises leading multi-discipline groups of employees, consultants and vendors to ensure resiliency against disasters and drive continuous improvement. Position Overview: The Data Center Resiliency Manager is collaboratively responsible for partnering with both the Data Center Operations Manager and the Disaster recovery Manger to ensure aligned services between the two functions.
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.
Regulatory & Clinical Affairs Manager PEAK Technical Services Inc.Regulatory & Clinical Affairs ManagerPrinceton, NJ$150,000–$185,000 / yearDesired CharacteristicsCollaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/ .
NewSenior Regulatory Affairs Consultant (Program / Client Partnership Manager) ParexelSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)Trenton, NJRemoteYou will play a key leadership role in managing midsize to large Regulatory Affairs outsourcing programs, partnering closely with clients and cross-functional teams to drive operational excellence, ensure delivery against regulatory objectives, and support the successful progression of development and commercial programs. Due to continued growth and the ongoing success of our Regulatory Affairs Consulting team, Parexel is seeking an experienced Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) to join our team.
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.
Senior Quality and Regulatory Manager Colorcon IncSenior Quality and Regulatory ManagerNorth Wales, PAThe Senior Quality and Regulatory Manager reports directly to the Site Director for West Point and No-Tox and maintains matrixed responsibilities to Global Quality, with dotted line reporting to the Global Head - Innovation, Quality and Regulatory Affairs. This role is critical in ensuring product integrity, regulatory compliance, and operational excellence across both manufacturing sites while aligning quality and regulatory objectives with business goals.
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.
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.
NewRegulatory & Clinical Affairs Manager PEAK Technical StaffingRegulatory & Clinical Affairs ManagerPrinceton, NJDesired CharacteristicsCollaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/
Manager, Regulatory Affairs - Cosmetics (Global) Church & Dwight Co IncManager, Regulatory Affairs - Cosmetics (Global)Princeton, NJ$110,900–$157,900 / yearChurch & Dwight is seeking a Manager, Regulatory Affairs - Cosmetics (Global) to serve as the regulatory subject matter expert for cosmetic products and lead regulatory strategy, risk assessment, and execution to enable compliant new product development (NPD), global market entry, and lifecycle maintenance. This role partners closely with R&D, Marketing, Quality, Legal, Supply Chain, and international subsidiaries/distributors to ensure products meet global regulatory requirements while supporting business growth and on-time product launches.
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.
Senior Regulatory Managers GSK plcSenior Regulatory ManagersCollegeville, PASite Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Italy - Siena, UK - London - New Oxford Street Posted Date: May 22 2026 Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.
Manager, CMC Vaccines Mature Projects, Regulatory Affairs GSK plcManager, CMC Vaccines Mature Projects, Regulatory AffairsCollegeville, PA$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Site Name: USA - Maryland - Rockville, Hamilton Montana, USA - Pennsylvania - Upper Providence Posted Date: Jun 9 2026 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
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.
REMOTE Flavor Regulatory Affairs Manager Actalent IncREMOTE Flavor Regulatory Affairs ManagerEast Windsor, NJRemote$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Proficiency with regulatory documentation such as TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin, Prop 65 documentation, and TTB submissions.
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, Global Regulatory Affairs Otsuka America PharmaceuticalSenior Manager, Global Regulatory AffairsTrenton, NJProvides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
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.
Senior Manager, North America Regulatory Liaison Johnson & JohnsonSenior Manager, North America Regulatory LiaisonSpring House, PennsylvaniaAnalytical 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 This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities.
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.
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.
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.
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.
Regulatory Operations Manager Actalent IncRegulatory Operations ManagerHarleysville, PA$105,000–$115,000 / yearThe position also manages regulatory and compliance support for customers, collaborates closely with internal stakeholders to maintain and improve the quality system, and proactively monitors the regulatory landscape to identify and address compliance risks. Establish and maintain a comprehensive regulatory operations program that supports cosmetics under MoCRA, OTC pharmaceutical products, medical devices, and other regulated product categories in all markets served.
Senior Manager, North America Regulatory Liaison 6084-Janssen Research & Development Legal EntitySenior Manager, North America Regulatory LiaisonSpring House, PennsylvaniaAnalytical 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 This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities.