- Daiichi Sankyo, Inc. (Bernards, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... governance processes, and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …she will interact with the Companion Diagnostics Lead, Non-Clinical Research, Medical Affairs and other stakeholders to support the program . Other ... research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and interact with key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . Relationships The Senior Medical Writer reports to a Director of ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Tris Pharma (Monmouth Junction, NJ)
- …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS)… 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
- 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Regulatory Affairs - Clinical (Neuroderm), may be ... plans to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs -...and procedural cross-functional + teams. + Ensures the overall program execution of high quality, effective IND, CTA, NDA,… more
- Stryker (Mahwah, NJ)
- …We are currently seeking a ** Senior Staff Regulatory ... is complete and meets regulations and expectations. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist,** you will support Stryker's… more
- Haleon (Warren, NJ)
- …uniquely ours. Care to join us. It isn't a question. **About the role** The ** Senior Manager, US Regulatory Affairs -Wellness** is responsible for end-to-end ... Science Biology, Chemistry) + 7+ years of experience with Regulatory Affairs + 5+ years working specifically...that consists of competitive pay and a comprehensive benefits program . This includes a generous 401(k) plan, tuition reimbursement… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... product development activities/meetings + Perform research to support the development of regulatory strategy for the assigned clinical development program +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- City of New York (New York, NY)
- …by the Federal, State and City authorities. - Work directly with the most senior personnel in the Department to prepare contracts and advise the Department on ... complex procurement and business affairs . Supervise the drafting of standard contract forms, stipulations,...participate in contract negotiations. - Advise on and/or oversee regulatory and legislative developments affecting the Department and, in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned. **In this role, a typical ... + Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with input from senior management. + Represent CMC/CP RA at program meetings and independently provide regulatory interpretation, position, and strategy for ... assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and… more
- Mount Sinai Health System (New York, NY)
- …faculty. InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety ... and industry funding. This position is responsible for translating regulatory knowledge relating to human research, including federal, state,... programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the… more
- Catalent Pharma Solutions (Somerset, NJ)
- …NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The Senior Regulatory and Compliance Specialist ... organization as it touches various functional areas including: Supplier Quality, Regulatory Compliance, DEA, and Quality Management Systems. This role is part… more
- Mizuho Corporate Bank (New York, NY)
- …The VP will also assist in the oversight of regulatory remediation program and associated reporting to senior management and regulators. The VP will ... Regulatory Relations - MUSO Regulatory Affairs Group About the Team...+ Manage various remediation workstreams to support the firmwide regulatory remediation program . + Support remediation oversight… more
