- Repligen (Waltham, MA)
- OverviewThe Senior Director , Global Regulatory Affairs will report directly to the VP, Global Quality.This role will be accountable for the Regulatory ... Management across the organization, is essential.ResponsibilitiesThe Senior Director Global Regulatory Affairs must have the ability to:Lead & develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (North Wales, PA)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...Regulatory Submissions, Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry. Education area of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and...Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director )… more
- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on ... Executive Director of Strategic Operations. This position interacts with senior leadership (Executive and Leadership Teams) and collaborates closely with key… more
- Merck & Co. (Upper Gwynedd, PA)
- …our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies ... Diagnostics, Next Generation Sequencing (NGS), Professional Networking, Project Management, Regulatory Affairs Compliance {+ 3 more}-Preferred Skills:Job Posting… more
- Merck & Co. (Upper Gwynedd, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... Job DescriptionThe Senior Director ( Senior Principal...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... design pull you in? Are you ready to experiment with us? The Position The Director Channel Strategy & Planning will play a critical role in shaping the future… 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
- Merck & Co. (Rahway, NJ)
- …Analysis, Problem Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director , the Senior Specialist will work closely with our… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Reporting to the Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities are to… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global health authorities....of trends and metrics across the development pipeline. The Senior Director will guide and support the… more
