- Novo Nordisk (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …make a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...regulatory labeling for multiple products across the oncology therapeutic area. + Provides strategic advice and guidance to… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director , Regulatory Affairs . This position...drugs is required. + Experience in the Pulmonary Hypertension Therapeutic Area is preferred. + Must have excellent communication… more
- Bausch Health (Bridgewater, NJ)
- …regulatory agency guidance. **KEY ACTIVITIES/RESPONSIBILITIES:** + Manages or represents Regulatory Affairs on the promotional review committees for ... interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... ability to apply complex scientific and expert regulatory advice and risk assessment for the development of...development of promotional campaigns and materials for an assigned product/ therapeutic area in order to help ensure the Company's… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... environment + Strong business acumen and the ability to see business drivers outside of regulatory affairs + Working knowledge of the Rx product NDA and labeling… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and attend device company HA meetings as appropriate + In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company ... + 7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and… more
- Novo Nordisk (Princeton, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Senior Director , CKD-Medical Affairs . Has direct supervisory responsibility for field ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...representatives in answering physicians questions + Works with Executive Director to define therapeutic area disease and… more
- Bausch Health (Bridgewater, NJ)
- …sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been developing innovative ... effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners with the ... of the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription drug distribution… more
- Cardinal Health (Trenton, NJ)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... 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
- AbbVie (Branchburg, NJ)
- …driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , Director , or Senior Director ... the development and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Assures that regulatory … more
- J&J Family of Companies (Raritan, NJ)
- …assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global ... Director , Late Development Clinical Lead - Retina -...responding to medical and compound-related issues * Working with Regulatory Affairs and GCO with regard to… more
- Novo Nordisk (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in other aspects of company activities in the assigned therapeutic area. Relationships Reports to the Executive Director… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …life by advancing the care of patients with life-threatening diseases. ** Director , Media Relations** **Job Description** Gilead Sciences seeks an exceptional and ... responsible for leading and managing media strategy and engagement for key therapeutic areas, working in close partnership with colleagues across Public Affairs… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development strategy, clinical program oversight, and oversight of clinical interactions with regulatory agencies within the I&I therapeutic area. This may ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development functions. MTPA is dedicated to improving the… more
- J&J Family of Companies (Raritan, NJ)
- Director , Medical Safety Officer: Immunology - 2406178041W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Immunology to ... to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular… more
- Sumitomo Pharma (Trenton, NJ)
- …changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development functions. MTPA is dedicated to improving the ... hope for all facing illness. As a senior memberof Medical Science, theSenior Director , Medical Science will lead the early- to late-stage development team(s) in… more