- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, ... of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process… 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...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… 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
- 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
- Aequor (Seattle, WA)
- ScientistLocation: Seattle, WA (100% Onsite)Assignment Length: 12 months contractTop Skills: PhD in immunology, cell biology, or a related discipline (or MS with ... experience is highly desirable, preferably within the biotechnology or pharmaceutical industry. PhD candidate with 0-2 years of experience is highly preferred. A… 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)
- …11 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with ... at least 6 years of relevant work experience post PhD defense.Required Experience and Skills: -For BS/MS candidates, at least 11 years of relevant work experience… 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
- Lundbeck (Bothell, WA)
- …group and department meetings; draft SOPs, development reports, and regulatory submission documents Provide cross-functional support to upstream/downstream process ... validation at contract labs/CMOs Contribute to analytical sections for regulatory submissions while ensuring high-quality data integrity and documentation… 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...at least 8 years of related experience; or a PhD is required. Degree in a relevant field such… more
- Merck & Co. (South San Francisco, CA)
- …data generation, analysis, and reporting to project teams, governance bodies, and regulatory agencies, and manage key timelines and milestonesLead and develop a ... group of PhD and non- PhD researchers, drive scientific innovation, and champion new enabling technologies to enhance functional capability and… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations ... a strong network internally and across the external academic and regulatory community and build collaborations across internal company departments and key… more
- Insmed Incorporated (San Diego, CA)
- …& interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. ... team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics.Provide medical… 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. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The successful candidate must function well ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
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