- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose… more
- Citigroup, Inc. (Tampa, FL)
- The Regulatory Reporting Manager -Securites Services accomplishes results through the management of small professional team(s) and department(s) or as an ... of how areas collectively integrate within the sub-function of Investor Services Regulatory Reporting domain as well as coordinate and contribute to the objectives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Randstad (Valencia, CA)
- Regulatory Affairs Manager Medical Device/Pharma client is looking for a Regulatory Affairs Manager to strengthen and help lead their QA/ Regulatory ... attitude, a bright mind, and an open disposition. The Regulatory /QA team works very closely together and is highly...and is highly collaborative, the ideal person has directly managed a team, coached and has experience in regulatory … more
- Central Garden & Pet (Dallas, TX)
- …and has an exciting opportunity for a skilled and experienced Food Safety and Regulatory Affairs (FSRA) Manager to join our team! This position reports to ... the Sr. Director, FDA Regulatory Affairs & Food Safety and will support all...as well as other Central business units. The FSRA Manager 's principal responsibility will be to ensure that Central… more
- Mondelez International (Richmond, VA)
- …to Lead the Future of Snacking. Make It With Pride. The Quality and Regulatory Compliance Manager ensures effective deployment of MDLZ risk-based Food Safety ... (BU/Category/Corporate) to ensure products made at the Richmond Bakery meet regulatory and Mondelez' requirements for Food Safety and Quality. Ensure the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Michael Page (Skokie, IL)
- …innovation, and integrity. Renowned for their steadfast commitment to quality, regulatory compliance, and consumer trust, they create cutting-edge products that not ... in the evolving landscape of health and nutrition. Job Description Regulatory Compliance Oversight: Ensure all products comply with applicable regulations and… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Joliet, IL)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …submission, and monitoring of PLAIR activities, prior to new product launch. Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and ... Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R&, D, Technical Operations Sales and Marketing, Quality, Clinical, Legal.… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (North Wales, PA)
- …specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance, Regulatory Documents, Science {+ 4… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... priorities and effectively delegate and assign activities to meet the business needsAbility to develop short and mid-range project plans that are realistic and effective at meeting goals.Strong analytical skills to drive operational milestones Influence… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... and regulatory documents. You'll be at the heart of a...of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help… more
