Scientific Director Senior Medical Director Medical Affairs - Global Oncology Pipeline Prostate Cancer AbbVie IncScientific Director Senior Medical Director Medical Affairs - Global Oncology Pipeline Prostate CancerFlorham Park, NJThe Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline provides medical and scientific input into core strategic and operational pipeline medical affairs activities for the prostate cancer portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline (Prostate Cancer) AbbVie, IncScientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline (Prostate Cancer)Florham Park, NJThe Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline provides medical and scientific input into core strategic and operational pipeline medical affairs activities for the prostate cancer portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
NewRegulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
NewSenior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90,000–$140,000 / yearThe Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Sr. Director, Regulatory Affairs Eikon Therapeutics, Inc.Sr. Director, Regulatory AffairsJersey City, NJ$235,000–$288,750 / yearThis role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.
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.
Head Global Oncology Pipeline Medical Affairs AbbVie IncHead Global Oncology Pipeline Medical AffairsFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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.
Associate Director, Regulatory Affairs Summit Therapeutics IncAssociate Director, Regulatory AffairsNY$168,000–$198,000 / yearThese assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned. Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other day-to-day regulatory activities of the studies as necessary and independently.
Senior Manager / Associate Director, Regulatory Affairs CMC Shionogi & Co LtdSenior Manager / Associate Director, Regulatory Affairs CMCFlorham Park, NJ$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.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistMahwah, NJ$28–$33 / hourCoordinate, prepare, and review regulatory documents and certifications for example: Specifications, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, BE/GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional. 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.
Staff Regulatory Affairs Specialist Becton Dickinson and CoStaff Regulatory Affairs SpecialistFranklin Lakes, NJ$135,500–$216,800 / yearFor most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
NewBusiness Affairs Analyst (Platform Distribution) The Walt Disney CoBusiness Affairs Analyst (Platform Distribution)New York, NY$70,240–$96,580 / yearIn this role, you will help build the future of video by developing and supporting contractual and business strategies for the Disney Platform Distribution group to advance the media networks, direct-to-consumer and digital transactional businesses. The Walt Disney Company, together with its subsidiaries and affiliates, is a leading diversified international family entertainment and media enterprise with the following business segments: media networks, parks and resorts, studio entertainment, consumer products and interactive media.
Senior Director, Global Regulatory Affairs, Neurology Eisai USSenior Director, Global Regulatory Affairs, NeurologyNutley, NJResponsibilities: Function as a Regional or Global Regulatory strategy lead and oversee regulatory submission activities and review regulatory documents (e.g., annual reports, protocol amendments) prior to submission to ensure overall quality, compliance and timelines. Direct, and manage financial planning/forecasting and budget management, vendor management, timeline development & tracking, and assess resource needs for respective program(s) within regulatory strategy.
Senior Director, Regulatory Affairs Summit Therapeutics IncSenior Director, Regulatory AffairsNY$203,000–$253,000 / yearOverview of Role: The Senior Director of Regulatory Affairs is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
NewSenior Director/Executive Director, Medical Affairs Nektar TherapeuticsSenior Director/Executive Director, Medical AffairsNYRemote$325,000–$400,000 / yearPartner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Commercial, Market Access, Medical Information, Corporate Communications, and Business Development to align evidence generation, scientific communications, launch readiness, and lifecycle strategy. Lead implementation of the Medical Affairs strategy for rezpegaldesleukin in atopic dermatitis and alopecia areata, converting strategic priorities into integrated plans for evidence generation, external scientific engagement, scientific communications, medical education, publications, field medical execution, and launch readiness.
NewRegulatory Affairs Director *PC 954 Miltenyi Biotec GmbHRegulatory Affairs Director *PC 954New Jersey, NJ$201,579–$237,206 / yearThese developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Essential Duties and Responsibilities: Develop and implement CMC regulatory strategies to support clinical development, marketing applications, and post-approval lifecycle management for cell and gene therapy products.
NewRegional Clinical Affairs Manager - Electrophysiology (EP) Abbott LaboratoriesRegional Clinical Affairs Manager - Electrophysiology (EP)NY$99,300–$198,700 / yearSpecific priorities include relationship development with Key Opinion Leaders (KOLs), leading new clinical site launches, identifying new clinical research partners, and developing strategic plans for research partnerships within territory. Clinical Site Management & Enrollment: act as the primary point of contact for clinical trial sites, proactively driving patient enrollment and ensuring study milestones are met.
Area Director, Government Affairs Vistra CorpArea Director, Government AffairsNJ$137,700–$246,100 / yearOversee team of external consultants that will assist in advocating issues on behalf of the company; manage and maintain accountability; educate on key issues. Experienced gained through college degree programs and or certifications and five years of government relations experience; prior employment in electric industry is strongly considered.
Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron PharmaceuticalsDirector, Regulatory Affairs Strategy - Genetics MedicineTarrytown, NY$205,000–$341,600 / yearThe Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.