- 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 ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing and ... of internal regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of their assigned projects.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk -Provide regulatory consultation in the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet… more
- Merck & Co. (Rahway, NJ)
- …audits to investigate frequent field alerts, recalls, rejects and complaints.Support in informing Senior Management of emerging regulatory and PV trends to help ... aspects of the operational business comply with GXP legal and Regulatory Requirements and the company's Animal Health Policies and Procedures.Job… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing relationships with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety… more
- Merck & Co. (North Wales, PA)
- …company's biopharmaceutical business.This position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical ... Job Description Position Description: Senior Specialist, Financial Planning & Analysis Our company's...analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, US East Coast ... Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing,… more
- Walmart (Bentonville, AR)
- …and developing plans for mitigating Walmart's regulatory risk . The Director actively partners with senior leaders across the business and global ... Position Summary What you'll do The ** Director for Global Regulatory Risk Assessment** is a critical role in the Global Governance Regulatory & Specialty… more
- JPMorgan Chase (Plano, TX)
- …the firm's tech risk strategy and enhance industry compliance. As a Tech Risk & Controls Director in Cybersecurity and Technology Controls, you will play a ... Expert Practice Lead with a deep background in audit, regulatory and industry risk assessments to join...and high-quality outcomes. + S **erve as a Strategic Risk & Control Advisor.** Partner with senior … more
- Morgan Stanley (New York, NY)
- We're seeking someone to join our team as a Director in Operations Risk and Regulatory Control to be responsible for the firm's daily Consolidated Audit ... diversifying its workforce (M/F/Disability/Vet). **Job:** **Other* **Title:** *Trade Transaction Regulatory Reporting Director * **Location:** *New York-New York*… more
- Citigroup (New York, NY)
- …Risk Data Assets. + Develop senior management-ready materials for RMEC ( Risk Management Executive Committee) and Regulatory Exams and review on ... Regulatory Business Critical Milestones delivery. + Drive change and influence risk and regulatory outcomes. Provide appropriately conservative solutions in… more
- Citigroup (Queens, NY)
- …and continue to enhance an effective internal control's structure to satisfy the MCA Risk and Controls requirements. + Lead regulatory exams, internal audits and ... reporting along with financial analysis in order to communicate results to Senior Management and US Regulatory Agencies. + Keep abreast of industry,… more
