- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Genmab A/S (Princeton, NJ)
- …fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of ... our Global Regulatory Affairs organization. In this role, you will work... risks and challenges and relevant mitigatory actions, to senior leadership and project team Prepare/oversee/review/maintain regulatory … more
- Twist BioScience (South San Francisco, CA)
- …leader to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing is responsible for leading all aspects of Twist's ... global marketing activities. This person will plan, develop and...to launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth… more
- Twist BioScience (South San Francisco, CA)
- Sr . Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... regulatory concepts.Ability to travel as required to support global biomanufacturing sites.Preferred QualificationsExperience with specific biopharmaceutical manufacturing processes… more
- Eli Lilly and Company (Indianapolis, IN)
- …over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... approval. Development of regulatory strategy and update strategy based upon global regulatory changes. Provide regulatory guidance to allow CMC teams to… more
- Merck & Co. (Rahway, NJ)
- …your leadership, technical skills, and scientific acumen as part of a global , cross-functional team . - Job Responsibilities - Responsible for leading specific ... clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development… more
- Merck & Co. (Upper Gwynedd, PA)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Repligen (Waltham, MA)
- … public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... processes including all global subsidiaries. Reporting directly to the VP Corporate Controller,...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report...Regulatory Affairs (GRA) and will report to the Sr . Director , Labeling, Policy and Intelligence. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand performance in alignment with overall business objectives. Relationships Reports to the Sr . Director , Wegovy Consumer Marketing . C ollaborates with sales, ... in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution of… more
- Merck & Co. (North Wales, PA)
- …to demonstrate your advanced leadership and technical skills as part of a global , cross-functional team. You will build and coach your team in the development ... execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
