Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.Director, Global Regulatory Affairs (GRL)Basking Ridge, NJ$193,040–$289,560 / yearFull timeThe GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.Associate Director, Companion Diagnostics LeaderBasking Ridge, NJ$166,720–$250,080 / yearFull timeContributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection.
NewManager, Drug Product Manufacturing Larimar TherapeuticsManager, Drug Product ManufacturingPhiladelphia, PAThe successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners. Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply.
Director, Healthcare Compliance Aquestive Therapeutics Inc.Director, Healthcare ComplianceWarren Twp, NJReporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership.
Senior Product Manager - Remote IntradoSenior Product Manager - RemotePhiladelphia, PARemote$120,000–$150,000 / yearWorking within Intrado’s product operating model, you will partner closely with Sales, Customer Success, Engineering, Network Operations, Product Operations, Regulatory Affairs, and telecommunications service providers to define and deliver solutions that meet evolving customer, industry, and regulatory requirements. The ideal candidate brings experience in telecommunications, emergency communications, or network-based services and has a strong understanding of Wireline, VoIP, NG911, location information services, and the public safety ecosystem.
NewPsychologist Community Behavioral Health.PsychologistPhiladelphia, PA$110,000–$120,000 / yearRelevant Work Experience: Minimum of 5 years of experience as a Psychologist treating children, adolescents and families providing services in the home, community and/or school; experience conducting biopsychological evaluations, making mental health diagnoses and working collaboratively with professionals across disciplines. The Psychologist Advisor provides consultation regarding overall quality of care, decision making, case formulations, and other safety concerns, specific to case review and levels of care or cohort.
Head of Commercial Operations Aquestive Therapeutics Inc.Head of Commercial OperationsWarren, NJGroup and project leadership (interaction with cross-functional partners, conflict resolution, and consensus-driving) and project management (planning, prioritization, objective setting, meeting management, and plan execution) with history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities. Demonstrated leadership focused on driving results and building successful team culture, a record of people management/development accomplishment, experience leading teams and cross-functional projects, and strong interpersonal, communications and presentation skills.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonRahway, NJ$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Regulatory Affairs Project Manager Colgate-Palmolive CoRegulatory Affairs Project ManagerPiscataway, NJ$124,000–$174,000 / yearEstablished in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses - Oral Care, Personal Care, Home Care and Pet Nutrition.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Bridgewater, NJ$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
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, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development.
Regulatory Affairs Project Manager (Piscataway, NJ, US) Colgate-Palmolive CompanyRegulatory Affairs Project Manager (Piscataway, NJ, US)Piscataway, NJ$124,000–$174,000 / yearRisk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties. Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging.
Director, Regulatory Affairs Americas , L''Oréal Research & Innovation L'Oreal USA IncDirector, Regulatory Affairs Americas , L''Oréal Research & InnovationClark, NJ$126,900–$184,000 / yearIn this pivotal role, you will bridge the gap between complex legislation and high-stakes business growth, defending our regulatory policies before major authorities like the FDA and CARB while ensuring our groundbreaking products reach the hands of our consumers safely and swiftly. A Day in the Life: As a strategic leader in Regulatory Affairs, your responsibilities include: Regulatory Compliance Excellence: Direct the strategy to ensure all products placed on the market comply with local, country, and federal regulations across the Americas zone.
Senior Scientist I, Regulatory Affairs, L''Oréal Research & Innovation L'Oreal USA IncSenior Scientist I, Regulatory Affairs, L''Oréal Research & InnovationClark, NJ$77,400–$110,300 / yearIn this role, you will be a pivotal force in ensuring that our innovations reach consumers safely, compliantly, and confidently - navigating the complex global regulatory landscape so our scientists and product developers can focus on what they do best: pioneering the future of beauty. Manage and prioritize regional regulatory projects, collaborating across countries and cross-functional teams to align timelines, resolve compliance challenges, and drive decisions that keep product launches on track.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorHopewell, New JerseySUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
Director, Regulatory Affairs - CMC PTC Therapeutics IncDirector, Regulatory Affairs - CMCWarren, NJ$193,500–$243,600 / yearWorks with GRA functions to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality. This position works cross-functionally with Regulatory Affairs, Technical Operations, Quality, and program teams to facilitate the completion of regulatory submissions through regulatory approvals in accordance with company goals and timelines.