Responsible for managing Med Legal Review (MLR) submissions for a variety of Pharma Brand companies, including submitting in MLR Systems Develop and maintain constant knowledge of pharmaceutical company requirements, including but not limited to system and regulatory guidance and annotation guidelines Partner with team leads to provide consultation to Account Managers on

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

Responsible for managing Med Legal Review (MLR) submissions for a variety of Pharma Brand companies, including submitting in MLR Systems Develop and maintain constant knowledge of pharmaceutical company requirements, including but not limited to system and regulatory guidance and annotation guidelines Partner with team leads to provide consultation to Account Managers on

Compliance Analyst Remote Job Locations US NJ EATONTOWN | US NJ Remote Job ID 2024 3667 Category Compliance & Audit Type Regular Division A&H Crum & Forster Company Overview Crum & Forster (C&F) with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus lines insurance companies. C&F enjoys a f

Dorman was founded on the belief that people should have greater freedom to fix motor vehicles. For over 100 years, we have been driving new solutions, releasing tens of thousands of aftermarket replacement products engineered to save time and money, and increase convenience and reliability. Founded and headquartered in the United States, we are a pioneering global organi

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide

Develop and administer trade compliance training to functional teams to enhance competencies in operational business scenarios. Collaborate with legal, finance, tax, and other functions as needed to make relevant trade compliance determinations. Develop, maintain, and communicate standards to operational teams via master data or other databases to facilitate business flow

Altice USA is a cutting edge communications, media, and tech company. We connect people to what matters most to them; texting with friends, advertising that resonates, or binge watching their favorite show. Our differentiated approach centers around technologies that push the envelope and deliver the ultimate customer experience. We're building a workforce that attracts a

Review all SpeakUp reports to identify emerging trends and create and implement relevant risk mitigation plans; Conduct or oversee internal investigations for the global organization from intake to closure; Supervise regional compliance investigators and other internal and external compliance resources as they conduct investigations. Advise on and, where appropriate, mana

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

Parexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe. In this role you will provide leadership in all regulatory an

The Mgr, Regulatory Compliance is responsible for the daily oversight and management of compliance activities across the assigned Horizon Line of Business (LOB). This position ensures that the Enterprise operates in compliance with applicable federal and state laws and regulations. The Manager will advise and influence business leaders across functional areas and implemen

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor