- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Regulatory Affairsis a strategic leader responsible for directing and managing regulatory strategies for multiple pipeline and contract manufactured products. ... a leadership role in interactions with the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance… 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
- 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...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance ... and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders. Participates in… 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
- 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
- Genmab (Plainsboro, NJ)
- …through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We have a hybrid model ... and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to incorporate insights into product… more
- Genmab (Plainsboro, NJ)
- …role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and others) and ... Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Lundbeck (Bothell, WA)
- …teams Collaborate with QC to support method transfer and validation at contract labs/CMOs Contribute to analytical sections for regulatory submissions while ... group and department meetings; draft SOPs, development reports, and regulatory submission documents Provide cross-functional support to upstream/downstream process… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well ... Responsibilities include but are not limited to:Collaborate with internal teams, contract research organizations (CROs), and external vendors to prepare, review and… more
- Genmab (Plainsboro, NJ)
- …with legal and compliance teams to ensure adherence to all regulatory requirements and ethical standards.Stay updated on biotech industry trends, competitive ... landscapes, and regulatory changes to inform strategic planning.Represent US interests in...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Genmab (Plainsboro, NJ)
- …experience with progressing innovative drugs through an industry pipeline towards regulatory approval. While your background might not encompass all CPQS expertise ... experience in immune-oncology preferredWorking knowledge of Health Authority and Regulatory guidelines for drug developmentSignificant experience building and executing… more
- Merck & Co. (Rahway, NJ)
- …validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.Perform investigations with strong technical ... troubleshooting skills.Provide documentation/technical input during inspections and audits ( Regulatory and Internal) and have a working knowledge of data… more
- Genmab (NJ)
- …(CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (ie, protocol, ICF, IB, safety updates, ... study reports, regulatory submissions, etc.) to support registration and commercialization of...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… 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 ... plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks,...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Genmab (Plainsboro, NJ)
- …in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Genmab (NJ)
- …and reporting in clinical trialsExperience and understanding of GCPs, SOPs, regulatory requirements and good data management practicesExperience working on early and ... late-stage submissions as per local/ regulatory requirementsExperience working in and leading cross-functional teamsFor US...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, attorney support on litigation matters (including products liability, employment, contract and patent matters), vendor management and support of other ... initial applications, and/or renewals. Responsible for tracking expiration dates and regulatory changes to ensure timely filing. Preparation of all applications and… more
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