- Genmab (Plainsboro, NJ)
- …regulatory guidance as relevant As assigned by management, provide regulatory due diligence assessment of licensing /acquisition opportunitiesRequirements BSc ... passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory... Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily responsible for the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory ... Primary responsibilities include, but are not limited to: Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Specialist will work as part of a global regulatory pharmaceuticals team to create and maintain global registration dossiers in the Veeva ... platform.The Specialist's responsibilities will include:Creating global and country specific regulatory dossiers in the Veeva Submissions Platform.Assisting with the… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ... within the confines of departmental Standard Operating Procedures (SOP) and regulatory guidance; responsible for authorship of equipment-related SOPs and job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Regulatory Affairs Intern for summer 2025. This full-time position works for approximately ... 37.5 hours per week. Responsibilities:Support Regulatory Affairs Chemistry, Manufacturing, and Controls team with Investigational New Drug Application and Biologic … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is responsible for processing and maintaining business and distribution license applications and renewals and acting as lead paralegal support and ... program both within Legal and Corporate Affairs and across the Company.- Licensing and Annual Reports: Responsible for the preparation, processing, filing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with CROs, License ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (South San Francisco, CA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).Provide clinical pharmacology ... internal and external opportunities identified by Business Development and Licensing .Interface broadly with key functions including Discovery Sciences, Preclinical… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory ... team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure timebound… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ.) required Experience Qualifications- 7 or More Years of post-law school ... experience required- 7 or More Years experience in regulatory , compliance, and legal matters relating to pricing and...New Jersey (either licensed in NJ or limited in-house license ) and maintain such license in good… more
- Merck & Co. (Rahway, NJ)
- …governance (early and late stage) Provide core TMed input at external licensing committee for Cardiovascular & Respiratory. Provide clinical updates at early ... submissions and NDAs Regular updates with key cross-functional partners (Discovery/Late-Stage/ Regulatory ), as well as other disciplines Establish novel endpoints for… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance ... are completed in accordance with identified target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …codes and regulations as required. Obtains and keeps current all required licensing and certifications associated with the jobPossesses experience and training in ... thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... aligned with strategic direction defined by the global business model and regulatory agencies.- The role will require working with Operations, Technology, Supply… more
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