Global Regulatory Affairs Manager

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients. and our edge comes from our team of people. **Role & Function** **Key Responsibilities** - Lead New Product Development for Medical Devices (including...

The mission of the Clinical Affairs group within Medical and Scientific Affairs is to create value for ImmunoDiagnostic Division (IDD) by providing clinical evidence for product pre-launch or post-launch across the portfolio. Main responsibilities for the unit are: - Own IDD clinical affairs planning, execution and reporting - Develop timely and...

**Position Summary**: We are looking for an** Associate Director, Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) **to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to provide regulatory CMC support for the development and commercialization of our products. This position will be...

General Description:_ Reports To: Director, Regulatory Affairs Essential Functions of the job: - Manage the preparation, assembly, review, and timely submission of Clinical Trial Application (CTA) and amendments through CTIS; Coordinate the internal response to questions from Health Authorities across Europe and provide guidance as needed. - Work cross...

General Description: The Director Medical Affairs Solid Tumors, Medical Affairs, EU is the internal key expert within the indication area(s), directly supporting the respective products through development, pre-marketing, launch, marketing support and lifecycle management. This includes all areas of medical affairs activities such as support of safe and...

The Clinical Project Manager’s responsibilities include operational delivery of strategic clinical studies assigned to the country, to support the sponsor’s pipeline, in accordance with ICH/GCP, SOPs, local operating guidelines and local requirements, as applicable. The Clinical Project Manager works locally, supporting Associate Director Clinical...

**DIVISION OVERVIEW** The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select in vitro diagnostic (IVD) market segments and has been a trusted supplier in the IVD industry for over 40 years. CDD provides products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening...

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

**Description** **Global Clinical Trial Assistant - Managed Access Programs** **Home based in Belgium, Italy, Germany, Switzerland, Spain, Netherlands or Portugal** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...

General Description: - The Global Clinical Compliance Lead (gCCL) is responsible for implementing the global clinical compliance and inspection management strategy across BeiGene clinical programs at study level, as assigned. The gCCL provides compliance and quality support to BeiGene GCO study teams for the assigned programs / studies and ensures that...

**Description** **Medical Affairs - Senior Biostatistician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...

**Global Quality Customer Lead** North America or Europe - Remote Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $40 billion and 100,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. When you are part of the team at Thermo Fisher Scientific,...

**The job**: As our new **Sr Market Development Manager** you will be joining our ImmunoDiagnostics Division (IDD) and will be responsible for executing the Market Development strategy and delivering on key initiatives for the IDD Portfolio in Western Europe, in collaboration with Regional Marketing, HEOR, Scientific & Medical Affairs and Commercial. The...

Wir unterstützen einen weltweit führenden Schweizer Industriekonzern exklusiv in der Suche und Auswahl des Supply Chain Managers, Global Accounts. Für diese neu geschaffene Schlüsselstelle im globalen Supply Chain Management suchen wir den Kontakt zu einer gut strukturierten, international erfahrenen Persönlichkeit mit hoher...

General Description: The Associate Director, COBA Operations and System Support (Global Medical Affairs) will serve as the point of contact for the technical operational needs of the Medical Affairs teams across Europe and support systems, tools, and other operational initiatives. The incumbent will work with the Field Medical teams globally in support of...

General Description: The Global Clinical Process Management Lead will champion the investigation, development and implementation of process management activities for Global Clinical Operations; Working collaboratively with relevant GCO team members globally, to ensure BeiGene GCO standards and processes are efficient, optimized and maintained in compliance...

About the job: The Red Hat Global Ecosystem team is looking for an experienced Global Partner Account Manager with a record of successfully delivering business results to lead our partnership with ABB. In this role, you will work closely with a wide range of teams to expand our capabilities globally and effectively contribute to growing Red Hat’s results...

**About the job**: - The Red Hat Global Ecosystem team is looking for an experienced Global Partner Account Manager with a record of successfully delivering business results to lead our partnership with ABB. In this role, you will work closely with a wide range of teams to expand our capabilities globally and effectively contribute to growing Red Hat’s...

Ready to join the future of work? Come join a remote and hybrid first*, global company spanning across the Americas, Europe, and Asia for A Job That Works for You. You will become among 2000+ Guardians worldwide, embracing YOUR unique approach to work. Our vision of the future of work is “Work In Any Way” which offers flexibility for where you work, it...