- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.Job Summary The Director is responsible for developing strategies for assigned product(s) and execution of HEOR and ... products, interfaces with cross-functional teams including marketing, market access, and medical affairs to align strategies, and partners with HEOR field team in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... project meetings.Provide guidance to peers and cross-functional team members regarding strategic regulatory issues.Develop timeline and strategic input… more
- Daiichi Sankyo, Inc. (Bernards, 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 ...Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input ... strategy globally will be preferred but not required.Experience in providing regulatory strategic input into the Oncology drug development preferred.Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry required.8 or More Years in regulatory affairsExperience in providing regulatory strategic input into the ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Merck & Co. (Rahway, NJ)
- …AVP, Strategic Planning & External Engagement leadership team (LT) and Director , Strategic Operations Team to conduct regular, actionable analysis and ... Job DescriptionThe Executive Director , Policy Development and Strategy is a key...a key leadership role in the Global Public Policy Strategic Planning & External Engagement team, with responsibility for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic … 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 ... for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict...both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... research areas centered around rare diseases and immune disorders.Summary Provide strategic leadership for all statistical programming activity related to study,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be responsible for ... more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible for managing the… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… 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 called ... upon to guide a team of Clinical Regulatory Affairs professionals providing strategic...to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical… more
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating...mission of NYGB + Ability to balance legal and regulatory issues with the business and strategic … more
- New York State Energy Research and Development Aut (New York, NY)
- …advice and strategic counsel with respect to NYGB's operations, transactions, regulatory issues, and general corporate affairs . The MD-L&R must be committed ... to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal...strategic counsel with respect to NYGB's operations, transactions, regulatory issues, and general corporate affairs . The… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …(RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional ... teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
