- Novo Nordisk Inc. (West Lebanon, IN)
- …drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and ... in all activities and interactions with others Physical Requirements Local and International travel: 0-5%. While performing this job employee work involves sitting… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... Regulatory Affairs organization.In this role, you will work in...connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose guiding its… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development… 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 ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr...connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose guiding its… more
- Insmed Incorporated (San Diego, CA)
- …of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%Travel RequirementsDomestic ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Merck & Co. (North Wales, PA)
- …legal and compliance colleagues across the Offices of General Counsel- including with US Regulatory Legal and International Legal & Compliance teams - to provide ... Offices of General Counsel team members. QualificationsEducation: Juris Doctor (or international equivalent) required Required Experience & Skills 10+ years of legal… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient resource management, and clear ... submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and ...tools and processes preferredAbility to travel up to 10% International travel may be required Daiichi Sankyo, Inc. is… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... US, have licensed our products in the US and international markets, and have a robust pipeline of innovative...Head of IT is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as… more
- Merck & Co. (Rahway, NJ)
- … regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Merck & Co. (Rahway, NJ)
- …the Company's vaccines pipeline, including during late-stage development, distribution and regulatory milestones, in a manner that reflects the Company's purpose and ... manage all communications across the vaccine portfolio and pipeline, including regulatory approvals, governing bodies, publications of scientific data and other… more
- Merck & Co. (Rahway, NJ)
- …disease and alliance teams, research and development, medical affairs, regulatory affairs, market access, outcomes research, manufacturing, market analytics, ... international and domestic operations, legal, scientific communications, professional education, training, and development to successfully navigate the internal and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Control System Technician or Certified Automation Professional from the International Society for Automation (ISA) preferred Work Experience: Bachelor's degree ... (5) year of direct engineering Pharmaceutical, Biotechnology or other regulatory industries experience preferred Knowledge, Skills, and Abilities: Strong knowledge… more
- Tris Pharma (Monmouth Junction, NJ)
- …that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in ... the US, have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic… more
- Genmab (Plainsboro, NJ)
- …plans? Then take this chance to come work with us at a fast-growing, international innovation powerhouse. The RoleYou will act as functional leader of our Clinical ... experience with progressing innovative drugs through an industry pipeline towards regulatory approval. While your background might not encompass all CPQS expertise… more
- Genmab (Plainsboro, NJ)
- …skill development.Oversee resource allocation and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific clinical ... and GCP audits and inspections.Mitigate operational risks and implement regulatory changes in collaboration with stakeholders.Strategic Planning and Operational… more
- Genmab (Plainsboro, NJ)
- …trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory discussions in relation to IMP/AMPManage project/trial specific planning ... drug supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and… more
Related Job Searches:
Director International Regulatory Affairs,
International,
International Regulatory Affairs,
International Regulatory Affairs Manager,
International Regulatory Affairs Specialist,
International Regulatory Specialist,
Regulatory,
Senior International Regulatory Affairs,
Specialist II International Regulatory,
Sr International Regulatory Affairs