- American Honda Motor Co Inc (Torrance, CA)
- …we want you to join our team to Bring the Future!Job PurposeThe Department Lead , Environmental Regulatory Affairs manages PRO's environmental regulatory ... interpretations for both existing and new/nascent business areas. Working with the Regulatory Affairs Division Lead , this position will help represent Honda… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy ... the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our… more
- Merck & Co. (North Wales, PA)
- …requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement the regulatory ... Work Experience Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Merck & Co. (North Wales, PA)
- …of a scientific strategy that differentiates versus competition Partner with Medical Affairs to lead Group Input Meetings Partner with key stakeholders ... Job DescriptionThe Scientific Strategy lead plays a critical role in the launch...interface with internal and external stakeholders, including US Medical Affairs , Regional Vaccine Medical Directors, Global Marketing, the Center… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team productivity, customer experience and operational efficiency. Consults with legal and regulatory affairs to address legal considerations and ensure AI ... with us? The Position The Artificial Intelligence (AI) Product Lead is a strategic role focused on defining and...across the organization, ensuring ethical use and compliance with regulatory standards. Stay informed on emerging AI trends and… more
- Merck & Co. (North Wales, PA)
- …and Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies ... topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with Quality and Continuous Improvement (QCI), Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective ... immune disorders. Summary This position is a Clinical Science lead position and will lead a group...Management)- Partner and collaborate with global marketing, global medical affairs , global payers and access and commercial business units… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …BD&L. Collaborates with cross-functional teams, including portfolio, marketing, medical, R&D, regulatory affairs , analytics, and other relevant NNI departments ... us? The Position The Pipeline and Early Commercial Strategy Lead will be at the forefront of shaping the...Work collaboratively with cross-functional teams including research and development, regulatory affairs , and commercial teams, to align… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an...life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... to maximize your potential with us? The Position The Director, CMR Insights Lead is responsible for leading the generation, integration and translation of insights… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within… more
