- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory ... to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in… more
- Merck & Co. (Rockville, MD)
- …product and regulatory policy matters under the supervision of the Executive Director , US Lead , US Regulatory Policy.Participating in industry and ... to support the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy, will include:Proactively monitoring emerging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …registration strategies adhere to therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead on projects ... as neededTeam Interactions: Provides US or global representation on project teams; may lead regulatory teams for more complex projects. Leads or supports global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... proposals. This role will engage with a range of internal and external stakeholders from across functions on key...focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, Diagnostic Development Teams) and to external diagnostic ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Fidelity TalentSource LLC (Boston, MA)
- …the vibrant Fidelity Capital Markets trading floor? \u00A0We are looking for a Director of Regulatory Reporting, a leadership position within the team that ... Director will act as a primary interface between internal trading desks, middle office teams, compliance, systems development...to deliver a solution to address these. \u00A0Issues with regulatory reporting, if not addressed, can lead … more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) ... the drug delivery and combination produce space to:Drive pipeline development. Lead the core engineering technical device development team(s) supporting individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...operational focus; ensuring to establish good working relationships with internal and external stakeholders, eg, Tech Unit, SMEs. Communicate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... Modality) for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until completion of the first CPV. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders ... quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound,...escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal… more
- Insmed Incorporated (Bridgewater, NJ)
- …of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology industry or ... of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical...latitude required in the role, and external market and internal value when determining a salary level for potential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal /external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Rahway, NJ)
- …respective categories in the Companion Animal Health market.In this new position, the Director , Parasiticide portfolio Marketing will lead the brand and product ... Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and… more
- Merck & Co. (Rahway, NJ)
- …business supporting the Disease Area Strategies for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing - ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to join a...Melanoma provides the opportunity to lead our early-stage disease area, playing a critical role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal /external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory , but ... immune disorders. Summary The Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …(iPDPs) for governance approval and provide oversight for LDT contributions for regulatory filings (NDA, labeling). Lead and drive team accountability and ... you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a...follow @JazzPharma on Twitter. Brief Description:The Late Development Team Lead (LDTL) is a critical role in the organization… more
