- Merck & Co. (Rahway, NJ)
- …and Skills: -The candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process ... strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This ... and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU SmPC, PIL,… more
- Merck & Co. (Rahway, NJ)
- … portfolio.-3. Collaborate with cross-functional partners, including R&D, Quality, Regulatory , Manufacturing, Technical Product Leaders, and Value Chain ... enhance technical support processes, optimize supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide US regulatory support and guidance as ... rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on… more
- Twist BioScience (South San Francisco, CA)
- …governance policies andprocedures to ensure data integrity. Regularly partner with product management, regulatory , finance on appropriate attributework flows and ... master data-related projects within the global, technology,commercial, IT, and or product supply organization. Supports new product launchreadiness through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to optimize brand performance and patient outcomes Product Evolution Oversee product strategy and regulatory activities related to new clinical data or ... and initiatives within the TA. This role is responsible for guiding product development and commercialization strategies for late stage and in-line assets within… more
- Aequor (Thousand Oaks, CA)
- …engineers Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for ... a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, 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 and collecting… more
- Merck & Co. (North Wales, PA)
- …processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers ... at our Company's R&D division (our Research & Development Division ) is looking for Product Manager - PV Case Intake and Processing. Reporting into Product Line… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Merck & Co. (Rahway, NJ)
- …years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval ... Job DescriptionOur company's Device Product & Process Development (DPPD) Team designs, develops,...products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionTitle: Associate Director, Product Marketing Owner - Scientific Strategy and Payer Access Team Lead, Heart FailureGeneral Description: Our commercial ... the world. Join our organization as a results-driven and visionary Associate Director, Product Marketing Owner - Scientific Strategy and Payer Access Team Lead for… more
- Merck & Co. (Rahway, NJ)
- … product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other ... Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, inhaled,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Process & Product Modeling Team in our Company Manufacturing Division seeks an experienced Associate Principal Scientist who will develop and ... tools for drug substance (upstream, downstream, and conjugation) and drug product manufacturing unit operations using a variety of process-modeling tools.-As a… more
- Merck & Co. (Durham, NC)
- …actively participates in project suite teams, as required.Direct support of regulatory inspections and audits.Direct support of validation activities and all other ... Change Control.Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.-Is expected to possess a high degree of problem-solving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) ... (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory ...on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …critical thinking skills Experience different disease-therapeutic areas, and associated regulatory areas including Product Labeling, Chemistry, Manufacturing and ... and immune disorders. We are currently seeking a Global Regulatory Affairs Intern for summer 2025. This full time...be assigned to projects to help and support the regulatory leads and will be required to manage their… more
- Merck & Co. (Durham, NC)
- …Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing ... new facility will be used to produce the bulk active ingredient, finished product , and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control… more
