Assist in the preparation of external reports, ESG disclosures, and surveys such as CDP, EcoVadis, S&P Global and others. Assist in the collection, analysis and management of data for ESG reporting frameworks and support work processes, policies, etc. Collaborate with various teams to address customer inquiries and requests related to ESG topics. Proactively identify oppo

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

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

(Primary function) Incyte's Discovery Chemistry Department is seeking an analytical chemist to provide LC/MS analyses and purification of small molecule compounds in support of drug discovery and development programs. He/She will join an analytical team providing methods for the separation, identification, and stability of key compounds in a fast paced and dynamic research

/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

/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 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

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

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

The Center for Public Health Law Research (CPHLR or Center) housed at Temple University's Beasley School of Law supports the widespread adoption of scientific tools and methods for mapping and evaluating the impact of law on health. The CPHLR team works by developing and teaching legal epidemiology methods; by researching laws and policies that influence health to support