Regulatory Submissions

Job Summary: Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations. This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice...

Job Summary: Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations.This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice to...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

50000 EUR - 50000 EUR - Hybrid - Munich, Germany, Germany - Permanent **Exciting Opportunity - Join a Global CRO as a Study Start Up Regulatory Submissions Expert!** We are thrilled to announce a fantastic opportunity to join our mid-size global CRO client as a Study Start Up Regulatory Submissions Specialist based in Munich, Germany. This role is a...

50000 EUR - 50000 EUR - Hybrid - Munich, Germany, Germany - Permanent **Exciting Opportunity - Join a Global CRO as a Study Start Up Regulatory Submissions Expert!** We are thrilled to announce a fantastic opportunity to join our mid-size global CRO client as a Study Start Up Regulatory Submissions Specialist based in Munich, Germany. This role is a...

Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time in an hybrid model, Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and...

**Description**:** GROWING WHAT MATTERS STARTS WITH YOU** Corteva Agriscience, the world's first dedicated agriculture start-up, serves to enrich the lives of those who produce and those who consume, ensuring progress for generations to come. Our employees fulfill this purpose everyday by building/participating in an inclusive culture where we encourage each...

Regulatory Affairs Manager - Rest of World Markets - Based in Germany/Ireland/RemoteRole can be relocated in Germany, Ireland or Remote working can be facilitatedThis position will be responsible for ensuring efficient and productive regulatory submissions, as well as assisting and collaborating in strategic drug development program implementation for Rest...

**Position: Regulatory Affairs CMC** **About the Company**: A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence...

**Linical Co.**, Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including...

Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. The job holder provides innovative approaches to resolve complex regulatory issues and increase speed to patients. **Roles & Responsibilities**: - CDx development:...

**Tasks & Responsibilities**: - Provide strategic advice to clients on quality aspects of drug development and regulatory requirements, collaborating closely with cross-functional experts within the team. - Ensure that the content of CMC work-packages and documentation align with the appropriate development phase, meet regulatory expectations, and...

Tasks and responsibilities We are looking for an experienced Regulatory Affairs professional to join our dynamic international consulting team and play a key role on a project for one of our key clients. Consult our clients in development and implementation of regulatory strategies, identifying the most efficient and compliant regulatory pathways...

**Passion for Innovation. Compassion for Patients.**: ***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)***: - limited until 31.10.2024 -**: **The position**: Provide support for EU Regulatory Procedural Management for assigned projects including all pre - and post-authorisation activities ensuring a smooth run of regulatory...

**Passion for Innovation. Compassion for Patients.**: ***Director/Sr. Director Regulatory Affairs** **Companion Diagnostics (M/F/x)**: ***Purpose of the function**: To provide Leadership for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products....

Clinical Regulatory Director*Based in Munich, Germany*This role supports cross-functional development teams engaged in innovative drug development (including small molecules, biologicals, and ATMPs) at all stages - from research through clinical development to MAA, NDA/BLA submission.ResponsibilitiesProvide strategic regulatory guidance to project...

With emphasis on product development and regulatory life cycle management in Europe and AMELA (Australia, Middle East, Eastern Europe, Latin America, Africa) this Senior Director position will provide regulatory leadership, guidance, project management and procedural focused strategy and support to assigned projects in a manner that is scientifically sound,...

**Description**: Corteva Agriscience, the world's first dedicated agriculture start-up, serves to enrich the lives of those who produce and those who consume, ensuring progress for generations to come. Our employees fulfill this purpose everyday by building/participating in an inclusive culture where we encourage each other to stay curious, think...

Join us today and make a difference in people's lives! Regulatory Affairs Specialist (M/F/d) Position Summary The Regulatory Affairs Specialist implements and conducts the activities required to obtain and maintain regulatory clearance for the company's medical device products. General Responsibilities - Participating on project teams to provide input to...

**Description**: At Corteva Agriscience, we grow what matters by putting consumers and customers at the heart of everything we do. We recognize that safe and sustainable food is a priority of our consumers, and we're here to ensure those goals are met. As a Global Regulatory Toxicologist at Corteva, you will be an integral part of a growing,...