- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is ... of the US Dossier Planning team. The Associate Director provides leadership and oversight to...INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...required. The incumbent can work remotely anywhere in the United States with reasonable access to an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey SummaryThe Associate Director , Clinical ... New JerseyResponsibilities Assigned:Oversee and manage all operational aspects of phase I-IV US based or global clinical trialsAct as primary point of contact for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- SYSCO (Warminster, PA)
- …and service.AFFIRMATIVE ACTION STATEMENT:Applicants must be currently authorized to work in the United States .We are proud to be an Equal Opportunity and ... and retained to ensure the minimum potential for loss.Preserves associate relations through regular department or pre-shift meetings.Maintains on-going… more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures + Maintain… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs...Skills, and Abilities: + 9-11 years of experience in US Regulatory Affairs in development, life cycle ... + Substantial knowledge of and experience interacting and negotiating with US regulatory agencies. + Strong working knowledge of global regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 TAU ... within our Global Regulatory Affairs organization, based remotely. + Partners with the...MS Project, OnePager, Office Timeline, SharePoint etc). **More about us :** At Takeda, we are transforming patient care through… more
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary interface… more
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + Serve as ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with- us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and ... Labeling + Anticipate and interpret key trends and changes in the global/ US regulatory environment and provide strategic guidance regarding development plans as… more
- Merck (North Wales, PA)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for development and ... **Job Description** Our Regulatory Affairs team bring new medical advancements to...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU… more
- Novo Nordisk (Princeton, NJ)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... plans, study designs, and regulatory submissions. Relationships The Associate Director...Approximately 10% overnight travel. May include travel outside the US . Qualifications + Education Level: + Minimum of BS/BA,… more
- Merck (West Point, PA)
- …and are grouped into center-led categories and regional operating teams. ** Associate Director , Supplier Development & Performance Management (SD&PM) Responsible ... global team of Supplier Development & Performance Management (SD&PM) Field Specialists/ Associate Director responsible for developing and managing supplier… more
