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.
NewDirector, Omnichannel - Global Oncology Medical Affairs Daiichi Sankyo, Inc.Director, Omnichannel - Global Oncology Medical AffairsBasking Ridge, NJ$189,600–$284,400 / yearFull timeDemonstrated experience in content management strategy including digitalizing and modularizing medical content; Proven leadership skills in a cross-functional global team environment; Experience in managing cross-functional teams, collaborating with diverse stakeholders and with the ability to influence without authority; Strong knowledge of industry best practices; Strong understanding of regulatory requirements and compliance considerations in the pharmaceutical industry; Excellent leadership and communication skills, with the ability to partner and work with teams across regions and functions required. Cross-team Collaboration: Work with a cross-functional medical affairs team including Franchise and GMAT leads, Region (Medical, Omnichannel, and Analytics) leads, Affiliate Medical Directors, Content Team, Scientific Engagement Team, Analytics and Data Teams to enable medical engagement strategy (i.e. medical journeys with associated outcomes) and enable capability pull-through.
Associate Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Associate Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$210,640–$315,960 / yearFull timeThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
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.
Director, Healthcare Compliance Aquestive Therapeutics Inc.Director, Healthcare ComplianceWarren, 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.
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.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
NewSenior Manager, Clinical Quality Larimar TherapeuticsSenior Manager, Clinical QualityPhiladelphia, PAPosition Overview: The Senior Manager, Clinical Quality serves as the study-level quality leader for the clinical quality assurance program for a clinical-stage biotechnology company focused on developing innovative therapies for patients with rare diseases through novel cell-penetrating peptide technology. This highly visible, cross-functional role partners with Clinical Operations, TMF Management, Biostatistics, Data Management, Medical Affairs, and external service providers to ensure the quality and integrity of clinical trial activities throughout the product development lifecycle.
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.
Associate, Global Compliance External Engagement Daiichi SankyoAssociate, Global Compliance External EngagementBasking Ridge, NJRemoteContractorConduct independent initial review (“first line review”) of all planned CBER requests originating from DSI Business Requestors to determine if they (1) require CBER review and (2) if proposed engagements comply with applicable healthcare laws/regulations, internal policy and procedure requirements. Interact directly and frequently with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to the review of CBER submissions.
Senior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsPhiladelphia, PAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
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.
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.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJ$30–$36 / hourThis role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Program Development Analyst (Regulatory Affairs Associate) Actalent IncProgram Development Analyst (Regulatory Affairs Associate)New Brunswick, NJRemote$35–$40 / hourThis position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Senior Specialist, Regulatory Affairs ImmunityBioSenior Specialist, Regulatory AffairsSummit, NJDesignated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Associate Director/Director, Regulatory Affairs Advertising & Promotions Tris PharmaAssociate Director/Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$160,000–$180,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Associate Director- PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.