Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
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.
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.
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.
NewVice President, Medical Larimar TherapeuticsVice President, MedicalPhiladelphia, PAD.O.) required; neurology or cardiology background preferred; 10+ years of pharmaceutical industry experience with demonstrated progressive increase in management responsibilities; Prior experience in neurology and/or rare disease preferred; Experience with activities related to Medical Affairs a plus but not required; Track record of meaningful and substantial support of Phase 2 and Phase 3 studies, such as medical monitoring activities (data, coding, and protocol deviation review), contribution to and review of documents (protocols, informed consent forms, clinical study reports), and interactions with relevant external stakeholders (key opinion leaders, investigators, data monitoring committee); Proven excellent writing, presentation, communication, leadership, organization, and problem-solving skills; Established understanding of good clinical practices (GCP) and best practices related to evidence generation and scientific communications; Demonstrated appreciation of the needs and culture of a small company environment; Robust knowledge of clinical development, regulatory requirements, and healthcare compliance. Specific responsibilities include: Lead the medical guidance and support of clinical development programs, ensuring prompt, facilitative, and high value collaboration with Clinical Operations and the cross-functional study teams; In coordination with Statistics and Quantitative Sciences, review data and assist with interpretation of data from clinical studies; Partner with Safety and Pharmacovigilance to ensure provision of medical input as needed; Support Medical Affairs activities; Review and approve documents related to the clinical development program; Represent Medical at internal meetings and provide definitive guidance and direction; Supervise direct reports and external contractors; Ensure compliance with relevant regulatory law and guidance; Present medical and scientific information at study site visits and congresses; Represent Larimar Medical in engaging with external partners, regulatory bodies, and other external stakeholders; Perform other duties as appropriate at the direction of the Chief Medical Officer.
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 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.
NewAssociate Director, Quality (Validation and Data Integrity) Larimar TherapeuticsAssociate Director, Quality (Validation and Data Integrity)Philadelphia, PAThe responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities: Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
NewAccount Management - Project Coordinator ECLAROAccount Management - Project CoordinatorLawrence Township, NJ$36.42–$38.63 / hourProject Coordination and Support: Assist with Client initiatives, which may include alliance management, portfolio strategy, biomarker initiatives, and clinical guidelines/pathways projects, including project documentation and stakeholder communications. Contract and Budget Coordination Support: Support Client team members in coordinating and finalizing project expenditures, purchase order creation, invoice processing, and related financial activities.
NewMedical Science Liaison Larimar TherapeuticsMedical Science LiaisonPhiladelphia, PAThe Medical Science Liaison (MSL) is part of the field-based medical affairs teams that plays an important role establishing, cultivating, and maintaining relationships with strategic external stakeholders, specifically key opinion leaders (KOLs) and healthcare professionals (HCPs) in relevant therapeutic areas. 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.
NewDirector of Strategy & Impact (Grants & Allocations) Jewish Federation of Greater PhiladelphiaDirector of Strategy & Impact (Grants & Allocations)Philadelphia, PAServe as primary liaison between S&I and other departments on all workflows, including but not limited to: FRD and S&I departments for grantmaking committees (JFRE, Weinberg, WOV) and philanthropic guidance for restricted gifts, including identifying funder priorities and community needs. Work with Chief Strategy & Impact Officer on strategic planning for the Strategy & Impact department, including working with the Director of Israel and Global Operations to align funding priorities, budget operations, and missions and lay leader travel, and restricted gift workflow.
NewSales Training Senior Manager/Director Aquestive Therapeutics Inc.Sales Training Senior Manager/DirectorWarren, NJAs a key member of the commercial organization, this individual will be responsible for building a comprehensive learning curriculum that equips sales leaders and specialty sales representatives with the knowledge, skills, and behaviors necessary for launch success and growth. The Director will partner closely with Sales, Marketing, Medical Affairs, Market Access, Legal, Regulatory, Compliance, and external partners to translate commercial strategy into effective, compliant, and measurable learning experiences.
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.
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.
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.
Associate Director, Regulatory Affairs Advertising and Promotion Recordati SpAAssociate Director, Regulatory Affairs Advertising and PromotionBridgewater, NJ$137,600–$180,000 / yearRecordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. This role is responsible for supporting regulatory review and activities related to advertising / promotion of our marketed pharmaceutical products in 1 or 2 of the following therapeutic areas: oncology, endocrinology, hematology.
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.