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.
Senior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.
NewPrincipal Customer Solutions Architect, Ads Regulatory Compliance MicrosoftPrincipal Customer Solutions Architect, Ads Regulatory ComplianceNew York, NY$142,800–$274,800 / yearAs the Principal Customer Solutions Architect, Ads Regulatory Compliance, you will operate at the intersection of product, engineering, policy, legal, operations, and business strategy to translate emerging regulatory requirements into scalable frameworks, governance models, and solution architectures. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $188,000 - $304,200 per year.
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.
Associate Attorney JobotAssociate AttorneyNew York, NY$160,000–$190,000 / yearWe're excited to announce that we are expanding our team and hiring a junior associate (fractional in-house Counsel) (1-3 years experience), who will work directly with a senior fractional General Counsel, supporting multiple crypto/fintech client accounts. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
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.
NewTransactional Construction Associate Attorney JobotTransactional Construction Associate AttorneyNew York, NY$180,000–$350,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. We are a leading AM 100 Law Firm specializing in corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs and employing some of the best and brightest attorneys.
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.
NewTravel RN - Telemetry - $2,124 per week HonorVet TechnologiesTravel RN - Telemetry - $2,124 per weekNew York, NYRole models the tenets of Mount Sinai Relationship Centered Care (MSHRCC) through facilitation of the following actions including, but not limited to, Admission Welcome, Bedside shift Report, HELP (High Risk Medications, Equipment, Lines/Drains/Airway, Pain and Plan of Care) AM/PM Care, 5 Minute Sit Down, Purposeful Hourly Rounding, Medication Review, Discharge Wrap Up, and MD/RN Unit Collaboration. As a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more.
NewTravel Nurse RN - Hospice - $2,848 per week HonorVet TechnologiesTravel Nurse RN - Hospice - $2,848 per weekBasking Ridge, NJAs a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more. Founded in 2015, HonorVet Technologies stands as a Service-Disabled Veteran-Owned Small Business (SDVOSB) , proudly certified by NaVOBA and the U.S. Department of Veterans Affairs .
Manager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
Executive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
NewTravel Neuro RN - $2,250 per week HonorVet TechnologiesTravel Neuro RN - $2,250 per weekNew York, NYAs a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more. Founded in 2015, HonorVet Technologies stands as a Service-Disabled Veteran-Owned Small Business (SDVOSB) , proudly certified by NaVOBA and the U.S. Department of Veterans Affairs .
NewTravel Stepdown Unit RN - $2,448 per week HonorVet TechnologiesTravel Stepdown Unit RN - $2,448 per weekNew York, NYAs a Joint Commission-certified clinical staffing agency , we deliver unmatched expertise in placing top-tier healthcare professionals—RNs, LPNs/LVNs, CNAs/CMAs, and NPs—across diverse facilities, including hospitals, clinics, rehabilitation centers, old-age homes, schools, correctional facilities, and more. Founded in 2015, HonorVet Technologies stands as a Service-Disabled Veteran-Owned Small Business (SDVOSB) , proudly certified by NaVOBA and the U.S. Department of Veterans Affairs .
NewSr. Director, Global Brand & Portfolio Management CSLSr. Director, Global Brand & Portfolio ManagementSummit, NJ$287,000–$352,000Oversees and guides continued global launch planning for aTIVc, including maximizing the portfolio opportunity across Fluad and aTIVc, refining the launch sequencing strategy, advancing business cases for key investments, and leveraging the Glocal brand marketing model (global to local division of activities) to drive efficiencies. Working in close partnership with R&D and cross-functional stakeholders, the role ensures alignment from research through commercialization, advances high-value strategic investments, and drives portfolio decisions that maximize mid- to long-term growth, value creation, and public health impact.
NewHead 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.
NewRegulatory Affairs Associate I The Fountain Group LLCRegulatory Affairs Associate IClark, NJBy applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Maintain registration support KPIs and monitor project timelines to ensure timely product registrations.
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.
Quality - Regulatory Affairs Associate Englewood Lab, Inc.Quality - Regulatory Affairs AssociateTotowa, NJ$58,000–$70,000 / yearGenerate Raw Material Regulatory Statements, including Origin Statements, Cruelty-Free Statements, Heavy Metal Statements, Impurity Statements, Food Allergen Statements, Fragrance Allergen Statements, Nitrosamine-Free Statements, PFAS, Benzene, and DEG/EG Statements. Generate and review Product CoCs, CoAs, CoMs, BSE documents, CMR documents, Raw Material Certificates of Analysis, Safety Data Sheets, technical documents, and raw material composition breakdowns, as may be required for local and international submissions.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJThis 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, NJ$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.
New["Regulatory Affairs Strategist, Globalization (US/ EU)","Regulatory Affairs Strategist, Globalization (US/ EU)"] Becton Dickinson NA["Regulatory Affairs Strategist, Globalization (US/ EU)","Regulatory Affairs Strategist, Globalization (US/ EU)"]Franklin Lakes$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best-practice sharing.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsManager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$128,600–$210,000 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
New["Regulatory Affairs Strategist, Globalization (eIPRRA)","Regulatory Affairs Strategist, Globalization (eIPRRA)"] BD (Becton, Dickinson and Company)["Regulatory Affairs Strategist, Globalization (eIPRRA)","Regulatory Affairs Strategist, Globalization (eIPRRA)"]Franklin Lakes$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible forimplementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategiesthrough tools, processes, and best‑practice sharing.
Regulatory Affairs Intern Phibro Animal Health CorpRegulatory Affairs InternTeaneck, NJPhibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.
Associate Director, Regulatory Affairs Advertising & Promotions Tris Pharma IncAssociate Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$180,000–$225,000 / 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. Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
Manager - Quality & Regulatory Affairs EnvistaManager - Quality & Regulatory AffairsMahwah, NJEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$150,500–$245,500 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Senior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
New["Regulatory Affairs Mfg Consultant","Regulatory Affairs Mfg Consultant"] Millenniumsoft["Regulatory Affairs Mfg Consultant","Regulatory Affairs Mfg Consultant"]Franklin LakesRequires the analysis of data, problem solving analysis, in depth evaluations of various factors and project management. This position is responsible for the preparation of International regulatory submissions required to market new or modified medical devices in Outside of the US (OUS).
NewAssociate Director, Regulatory Affairs Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Senior Analyst, Regulatory Affairs Oscar Health IncSenior Analyst, Regulatory AffairsNew York, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Director, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer) Mitsubishi UFJ Financial GroupDirector, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer)New York, New YorkAdditionally, our Total Rewards program provides colleagues with a competitive benefits package (in accordance with the eligibility requirements and respective terms of each) that includes comprehensive health and wellness benefits, retirement plans, educational assistance and training programs, income replacement for qualified employees with disabilities, paid maternity and parental bonding leave, and paid vacation, sick days, and holidays. Operating within the Compliance function and the Three Lines of Defense framework, the role serves as a trusted advisor to senior leadership and is responsible for driving regulatory readiness, enhancing governance practices, and promoting a culture of accountability, transparency, and continuous improvement across the U.S. broker-dealer environment.
Sr. Regulatory Affairs Specialist VB Spine LLCSr. Regulatory Affairs SpecialistAllendale, NJ$100,000–$105,000 / yearAs a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.
Director, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer) MUFG Americas Holdings CorpDirector, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer)New York, NY$185,000–$242,000 / yearAdditionally, our Total Rewards program provides colleagues with a competitive benefits package (in accordance with the eligibility requirements and respective terms of each) that includes comprehensive health and wellness benefits, retirement plans, educational assistance and training programs, income replacement for qualified employees with disabilities, paid maternity and parental bonding leave, and paid vacation, sick days, and holidays. Operating within the Compliance function and the Three Lines of Defense framework, the role serves as a trusted advisor to senior leadership and is responsible for driving regulatory readiness, enhancing governance practices, and promoting a culture of accountability, transparency, and continuous improvement across the U.S. broker-dealer environment.
Regulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerWoodcliff Lake, New JerseyFull timeJob DescriptionJob Position: Global Regulatory Affairs – Strategy ManagerDuration: Fulltime PermanentManager, Global Regulatory Strategy (GRS) will be a forward-facing role, representing GRS on project teams and communicating strategic options, issues and risks to a broad range of Stakeholders in an end-to-end pharmaceutical business model (R&D through commercial).The candidate will have the opportunity to research, develop and implement regulatory strategies to facilitate global approval of new medicinal products. Candidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR).A working knowledge of relevant drug laws, regulations and guidance's/guidelines is highly desirable.
Director, Regulatory Affairs Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Senior Associate, US Regulatory Affairs BeOne Medicines AGSenior Associate, US Regulatory AffairsNY$93,600–$123,600 / yearThe Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
Regulatory Affairs Admin Asst Life's WORCRegulatory Affairs Admin AsstGarden City, New YorkExcellent verbal & written communication skills, excellent organizational & time management skills, as well as excellent customer service skills. Assist with follow up on incident items needed from various departments to ensure incidents are completed/closed within the regulatory timeframe.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncAssociate Manager, Regulatory Affairs Strategy - OncologyTarrytown, NY$109,900–$179,300 / yearDiscover your role: Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Sr. Regulatory Affairs Specialist Integrated Resources, IncSr. Regulatory Affairs SpecialistEdison, New JerseyFull timeRegulatory Affairs SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. This is a Direct Hire role with the clientJob DescriptionJOB SUMMARYThis person will be a Regulatory liaison between product development and the regulatory agencies.
Director, Regulatory Affairs - CMC Rocket Pharmaceuticals IncDirector, Regulatory Affairs - CMCCranbury, NJ$204,000–$244,000 / yearThey will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs. Rocket Pharma is seeking a Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy.
New["Spec 3, Regulatory Affairs","Spec 3, Regulatory Affairs"] Trice Healthcare["Spec 3, Regulatory Affairs","Spec 3, Regulatory Affairs"]Franklin Lakes2/23 at 9:00 Am eastern Microsoft Teams meeting Join on your computer or mobile app Click here to join the meeting Join with a video conferencing device Video Conference ID: 119 379 792 2 Alternate VTC dialing instructions Or call in (audio only) +1 862-294-2579,,12316510#United States, Newark Phone Conference ID: 123 165 10# Find a local number | Reset PIN. Programs: Proficient in: Microsoft word, excel, adobe acrobat editor, and veeva vault Education: BS.B.Sc.,
Regulatory Affairs Strategist, Globalization (eIPRRA) Becton Dickinson and CoRegulatory Affairs Strategist, Globalization (eIPRRA)Franklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.
Regulatory Affairs Strategist, Globalization (US/ EU) Becton Dickinson and CoRegulatory Affairs Strategist, Globalization (US/ EU)Franklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization, is responsible for implementation of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across the BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best‑practice sharing.
Senior Manager / Associate Director, Regulatory Affairs CMC Shionogi Inc.Senior Manager / Associate Director, Regulatory Affairs CMCFlorham Park, New Jersey$140,000–$200,000 / yearServe as the primary CMC regulatory liaison with Health Authorities for designated assets, which involves guiding agency communications, creating briefing documents, handling information requests, and ensuring alignment with management on strategic or high‑risk issues before making commitments. Excellent verbal communication skills, with demonstrated ability to act as a regulatory CMC spokesperson and effectively communicate aligned regulatory CMC strategies and positions across working teams, cross‑functional forums, and senior leadership.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsJersey City, New Jersey, United States, New JerseyMonitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.