Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory stra...
Communicate directly with sites to enable start-up and maintain an active collaboration with sitesIdentify, communicate, and resolve issuesEnsure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems. ...
Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on ...
We are looking for an Associate General Counsel to join our Legal & Compliance team as our lead product and regulatory attorney, as we navigate evolving laws and regulations in healthcare, payments, consumer marketing/advertising, consumer and data privacy, and AI. Develop and communicate a visi...
Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on ...
Provide thought leadership expertise via analyses and external dissemination of key regulatory insights and implications on commercialization strategies·Understand intersection of regulatory strategy with commercial and market access stakeholders·Drive business development with key regulatory affair...
Quality Associate Director of Regulatory Intelligence. The Quality Associate Director ,Regulatory Intelligence. Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project teams in support of Labcorp presentations and journal publications, an...
Donnelley Financial Solutions (DFIN) is a leader in risk and compliance solutions, providing insightful technology, industry expertise and data insights to clients across the globe.We’re here to help you make smarter decisions with insightful technology, industry expertise and data insights at every...
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activ...
Job Title: Project Manager (Health & Welfare Projects). We are looking for a motivated and detail-oriented Project Manager to support project management activities, vendor management, and client deliverables within the health and. ...
The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products); participates on global cross-functional teams ensuri...
Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. Represents CMC RA in project team meetings and provides regulatory guidance and perspective to t...
Analyst, Compliance (Transaction Monitoring). In this role, you will work with a team of experienced compliance professionals responsible for critical functions within the Compliance and AML/BSA/Sanctions program. Compliance at Gemini is a team dedicated to managing the next generation of financial ...
Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk ass...
We are inviting professionals in high-growth industries who are thinking about their next move or looking for a new opportunity to join our expanding talent pool.The Marlee Talent Pool is a pilot project designed to:.Help job seekers get discovered by our partners based on their anticipated hiring n...
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies. Prepares regulatory plans and prepares needed regulatory submissions and as...
In this highly visible role, the Technical Project Manager will be part of a growing technical project management group in support of NPI process development and developing solutions for high-volume production. The Technical Project Manager is responsible for driving factory readiness to mass-manufa...
Work closely with the NYSERDA Program Manager to ensure timely planning, management, and tracking of progress, including analysis and reporting of related data points and benchmarking across the program's work streams Follow up on action items for a team across multiple departments in NYSERDA and DE...
The Senior Governance, Risk, and Compliance (GRC) Security Analyst is responsible for supporting the security direction of the business and elevating the company’s security posture. The Senior GRC Security Analyst is expected to support the security strategy of the business within new and existing i...
As the Senior Regulatory Manager, your role involves managing client and stakeholder expectations, navigating regulatory processes, and creating solutions for complex regulatory challenges that contribute to producing high-quality pharmaceutical products. Role: Senior Regulatory Affairs Manager. Wit...
The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. Primary responsibilities will...
Security Risk and Compliance Analyst will operate within a divisional security team reporting to the Director of Information Security. Analyst will be responsible for risk assessment, reporting and audit of Customer facing applications supporting the Tax and Accounting (TAA) and Corporate Performanc...
The Regulatory Specialist will play a crucial role in ensuring that all snack products comply with food safety regulations and labeling standards. This position is responsible for both regulatory compliance and consumer complaint management, focusing heavily on food safety, quality assurance, and la...
Ensure site readiness and adherence to project timelinesAdvises on project plan and responsible for daily updates on project status and activities. Healthcare Customer Project Manager – Onsite in Illinois, Wisconsin and Iowa. Your role as a Customer Project Manager will be to manage multiple patient...
Gartner analysts are industry thought leaders who create must-have research and provide advice to world-leading organizations. Analysts possess a keen eye for identifying gaps, problems and solutions within the market they serve, and help clients make better decisions relative to their highest busin...