- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Senior Director , Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug ... individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Title | Role: Director , Professional Relations - Specialty Dermatology Sun Pharmaceutical Industries, Ltd. (Sun Pharma) is the fourth largest specialty generic ... is bound by our common values:Humility. Integrity. Passion. Innovation.Job Summary:The Director , Professional Relations - Specialty Dermatology is a key member of… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Senior Director of Translational Medicine and Clinical Pharmacology Sun...sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs , and late-stage clinical research Qualifications:… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …head of NA HEOR and cross-functional teams, including members of medical affairs , clinical development, regulatory , market access, and commercial. Develop HEOR ... Princeton, New Jersey (ONSITE: Hybrid 3 days in office; 2 days remote) Director , Health Economics & Outcomes Research Summary:Sun Pharmaceuticals, one renowned global… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …head of NA HEOR and cross-functional teams, including members of medical affairs , clinical development, regulatory , market access, and commercial. Develop HEOR ... New Jersey (ONSITE: Hybrid 3 days in office; 2 days remote) Director , Health Economics & Outcomes Research Summary: Sun Pharmaceuticals, one renowned global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated ... drug/diagnostic regulatory and submission plans), including HA engagement plans and...engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...support representatives in answering physicians questions Works with Executive Director to define therapeutic area disease and treatment concepts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement ... to the patients who need them.Responsibilities- With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …number of stakeholders across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the integration of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive organizational action, guide the Business units and the Clinical, Medical, and Regulatory Affairs (CMR) teams on strategy development and execution. This ... Are you ready to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the generation, integration and translation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
