- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited ... Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead Dossier planning team meetings...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Catalent (San Diego, CA)
- …or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The primary responsibilities… more
- Catalent (Manassas, VA)
- …and SQF Demonstrated leadership in the areas of food safety and plant regulatory affairs ; Strong organizations and leadership skills; ability to analyze ... formulation and analytical services to solve difficult development and manufacturing challenges.The Quality Assurance Supervisor will lead Food Safety and … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of relevant and current work experience in pharmaceutical / biotech / CDMO industry Quality Assurance and Regulatory Affairs required10+ years of progressive ... Design and implement programs, policies, and practices to ensure Quality Assurance and GxP compliance, and lead ...all inspection/ audits in compliance with local and global regulatory agencies.Respond to requests from regulatory agencies.… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... clinical and financial contracts within fair market value.Contribute or lead initiatives and projects adding value to the business,...include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead ...and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… 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 ... PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and experience working in a matrix environment with other functional groups (eg. Regulatory , Medical Writing, Med Affairs , Commercial) In-depth knowledge of Good ... Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA...areas of Global Development and US Clinical, Medical and Regulatory (CMR). Your skills, dedication and ambition will help… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs , Regulatory , Privacy, Sales, and Legal. Will also interact ... across multiple therapeutic areas/brands to ensure scalability, cost savings and alignment Lead and/or participate in key TA/Brand governance teams as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creation, and marketing execution. Relationships Reports to HCP Experience Lead . Collaborates with key external and internal cross-functional teams, including ... analytics, therapeutic area marketing leads, sales, medical affairs , and channel leads to align marketing tactics with overall brand goals and insights. Works… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next CSL Plasma Lead for Global Regulatory Affairs , Plasma? This position is located in our ... contribute to the vision, goals and improvement of Global Regulatory Affairs and includes collaboration with external...to enable a and planning to future our requirements. Lead regulatory strategies and activities globally -… more
- Citigroup (Tampa, FL)
- …require significant project management and stakeholder engagement to ensure that regulatory affairs are thoughtful, comprehensive and culminate in consistent ... across the various risk segments. **Team Overview:** The Risk Regulatory Affairs team ensures the Independent Risk...Lead production of reporting to senior management on regulatory feedback and key thematic findings to drive awareness… more
