- Merck & Co. (North Wales, PA)
- …for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... Job DescriptionThe Director, Regulatory Affairs Liaison, is responsible for...all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and… more
- Eisai, Inc (NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical Affairs and ... to hear from you. The Medical Director, US Medical Affairs provides medical leadership for medical affairs ...area to provide strategic input for the development of product strategies and liaises with external stakeholders to solicit… 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 ... Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This… more
- Merck & Co. (Rockville, MD)
- …in partnership with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and ... Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product applications and other related interactions… more
- Tris Pharma (Monmouth Junction, NJ)
- …is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) ... The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality, etc. to identify, evaluate… more
- Eisai, Inc (Nutley, NJ)
- …key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical Affairs and ... Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area. Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... and Reimbursement, Finance, IT, etc. Other internal relationships include Public Affairs and CMR. External relationships include relations with external consultants,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this...as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE). -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to epidemiology strategy for assigned products. Collaborate with epidemiology colleagues and Product Safety Lead to identify research gaps, develop protocols, ... and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to… more
- Fidelity TalentSource LLC (Boston, MA)
- …standards in the areas of accuracy, ethics, legal, and complianceWorking across Corporate Affairs and with business partners (eg, HR, Strategy & Finance, Product ... is part of the Associate and Leadership Communications organization within Corporate Affairs . Working closely with the most senior leaders within the Fidelity Wealth… more
- Novanta Inc. (Sarasota, FL)
- …of cooperation with the departments: Purchasing/ Service/ Production/ QM/ Manufacturing Engineering/ Regulatory Affairs / PM and with customers as well as ... monitoring and reporting. Primary Responsibilities Managing of large-scale projects for product development (NPI) Creation and monitoring of project plans incl.… more
- Fidelity TalentSource LLC (Smithfield, RI)
- …implemented.Collaborating with the System Department, Fidelity Retail Investment Service, Product /Project Managers and Administration and Government Affairs to ... weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily...is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent).… more
- ICP Group (Andover, MA)
- …and the Asia Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all ... credential portfolios. + Review all printed materials, including product labels, for compliance with regulatory requirements,... product compliance, regulatory compliance and/or product stewardship experience. + BS in Safety ,… more
- L'Oreal USA (Clark, NJ)
- …the Development Labs from multiple brands in Skin Care & Cleansing categories, as well as Product Safety , Regulatory Affairs and Claims Legal teams. As a ... clinical evaluation required + 2-3 years of experience in regulatory or OTC product testing within cosmetics,...will not be considered. Our Safe Together Plan: Your safety is our highest priority. We will proceed with… more
- Indorama Ventures (Houston, TX)
- … toxicologist as a Product Safety Toxicologist for our global Regulatory Affairs organization. The position will be based at our division's headquarters ... working a hybrid office/remote schedule. The Product Safety Toxicologist will report directly to the Regulatory... Safety Toxicologist will report directly to the Regulatory Affairs Director. **What will be expected… more
- AbbVie (North Chicago, IL)
- …Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety , Regulatory Affairs (RA) and Medical Affairs (MA) QA team ... across all stages of discovery and development for the product 's lifecycle to achieve product realization and...stakeholders including but not limited to Pharmacovigilance and Patient Safety , Regulatory Affairs and Medical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …with managing a Regulatory team. + Expert understanding of post-market drug product related Regulatory Affairs activities. + Outstanding knowledge of ... evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development and execution of the… more
