Regulatory Specialist
vor 7 Monaten
**Job summary**:
As a **Regulatory Specialist **you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in Germany. Reporting to **Clinical Operations Manager**, you will be a key member of the Clinical Operations team in the country.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward submissions and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
**Main Tasks of the Position**:
- Participates in all activities that lead to start up of investigational sites
- Takes part in the communication with Regulatory Authorities and Ethics Committees
- Interacts with Customers when receiving requirements from Regulatory Authorities
- Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures
- Provides training and support to CRAs in order to collect all necessarily documents for start up package and IP release
- Close collaboration with Regulatory Lead and Project Team during entire project
**Required Qualifications, Experience, Competencies**
- Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
- Open to learn and develop
- Excellent organizational and time management skills
- Skills to handle multiple priorities and to work with deadlines and under pressure
- Excellent written and oral communication skills
- Fluent in written and verbal English and German
- Computer skill
**Benefits**:
- Working with experienced and very professional and supportive team
- Possibility to grow within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme
-
Regulatory Affairs Specialist
vor 5 Monaten
Duesseldorf, Deutschland Clearstone GmbH VollzeitOur client is a world leading Pharmaceutical company, for their Munich office they're currently looking for a: **Regulatory Affairs Specialist - Munich** This role is integral to our Regulatory Affairs department, specifically catering to the European Market. We seek a meticulous professional to oversee all regulatory affairs and quality assurance...
-
Specialist Regulatory Reporting
vor 5 Monaten
Duesseldorf, Deutschland Statkraft VollzeitSpecialist Regulatory Reporting (f/m/d) - Full-time - Business Units: MR - Operations & Risk **Company Description**: Statkraft has been making clean energy possible for over a century. That’s what we offer. 125 years of unrivalled expertise in supplying the world with what it needs most. Because in the fight against climate change, we don’t see...
-
Specialist Regulatory Reporting
vor 5 Monaten
Duesseldorf, Deutschland Statkraft Vollzeit**Company Description** Statkraft has been making clean energy possible for over a century. That’s what we offer. 125 years of unrivalled expertise in supplying the world with what it needs most. Because in the fight against climate change, we don’t see renewable energy as part of the solution. We believe it must be the solution. With us, you’ll shape...
-
Food Regulatory Specialist
vor 5 Monaten
Duesseldorf, Deutschland Intersnack Deutschland SE VollzeitWir sind stolz darauf, der führende Hersteller im Bereich salzige Snacks in Deutschland zu sein und als Teil der Intersnack-Group auch europaweit zu den Marktführern im Bereich Salzige Snacks zu gehören. Mit unseren fünf deutschen Produktionsstandorten und unserem Campus in Köln vertreiben wir bekannte Marken wie funny-frisch, ültje, Chio, POM-BÄR und...
-
Local Start-up Specialist, Dach
vor 6 Monaten
Duesseldorf, Deutschland Allucent VollzeitThe Local Start-up Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS may also perform site...
-
Local Start-up Specialist I/ii
vor 5 Monaten
Duesseldorf, Deutschland Allucent VollzeitAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and...
-
Local Start-up Specialist I/ii
vor 5 Monaten
Duesseldorf, Deutschland Allucent VollzeitThe Local Start-up Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS may also perform site...
-
Senior Legal Counsel or Regulatory Specialist
vor 5 Monaten
Duesseldorf, Deutschland Uniper VollzeitOur International Law & Global Trading team within our Legal & Compliance business function in Düsseldorf is looking for you! **We are Uniper** At Uniper, we are pro-actively transforming the world of energy whilst at the same time ensuring security of energy supply. As an internationally operating company, we work in very diverse teams with the greatest...
-
Cgn : Reach Specialist
vor 6 Monaten
Duesseldorf, Deutschland Lonza VollzeitGermany, CologneREACH Specialist Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....
-
Quality Assurance Specialist
vor 5 Monaten
Duesseldorf, Deutschland AGAP2 VollzeitWir sind **agap2**, ein Unternehmen für operatives Consulting in den Bereichen Science und Engineering. Wir sind ein starkes Team aus Ingenieur:innen, Pharmazeut:innen und Naturwissenschaftler:innen. Wir helfen unseren renommierten Kunden, komplexe Projekte erfolgreich durchzuführen - von Inbetriebnahmen von Anlagen über Prozessoptimierungen bis hin zu...
-
Lcv Aps-2 Germany: Specialist, Hse
vor 6 Monaten
Duesseldorf, Deutschland KBR Vollzeit**Title**: LCV APS-2 Germany: Specialist, HSE - Contingency **_ Belong, Connect, Grow, with KBR! _** **Program Summary** **KBR** leads the government services world contingency market by providing responsive, full-service logistics support to forces deployed around the world under the **Logistics Civil Augmentation Program contract** (**LOGCAP**). KBR’s...
-
Study Start Up Specialist
vor 5 Monaten
Duesseldorf, Deutschland Alimentiv VollzeitSupport Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and...
-
Esg Reporting Specialist
vor 5 Monaten
Duesseldorf, Deutschland Birkenstock Group B.V. & Co. KG VollzeitBIRKENSTOCK is a global brand which embraces all consumers regardless of geography, gender, age and income. The company is deeply footed on a family tradition of shoemaking that can be traced back to 1774. With around 6200 employees worldwide, BIRKENSTOCK is the largest employer in the German footwear industry. To ensure our quality standards, we produce...
-
Lcv Aps-2 Germany: Sr. Specialist, Hse
vor 6 Monaten
Duesseldorf, Deutschland KBR Vollzeit**Title**: LCV APS-2 Germany: Sr. Specialist, HSE - Contingency **_ Belong, Connect, Grow, with KBR! _** **Program Summary** **KBR** leads the government services world contingency market by providing responsive, full-service logistics support to forces deployed around the world under the **Logistics Civil Augmentation Program contract** (**LOGCAP**)....
-
Senior Legal Counsel
vor 5 Monaten
Duesseldorf, Deutschland Uniper VollzeitFür unser International Law & Global Trading Team innerhalb unserer Business Function Legal & Compliance in Düsseldorf suchen wir DICH! **Wir sind Uniper** Wir bei Uniper treiben aktiv die Energiewende voran und sorgen zeitgleich für Versorgungssicherheit. Wir arbeiten als international agierendes Unternehmen in sehr diversen Teams bei größtmöglicher...
-
Contracts Officer in a Specialist Contract Research
vor 5 Monaten
Duesseldorf, Deutschland ARCHIMED Vollzeit**About the company** CRO is a leading Clinical Research Organization dedicated to advancing healthcare through innovative research solutions. With a focus on delivering high-quality clinical trials and comprehensive services, we strive to make a meaningful impact on patient care worldwide. **Requirements**: As a Contract Officer within our Contract...
-
Contract Implementation Specialist
vor 5 Monaten
Duesseldorf, Deutschland Statkraft VollzeitContract Implementation Specialist (f/m/d) - Full-time - Business Units: MR - Operations & Risk **Company Description**: Statkraft has been making clean energy possible for over a century. That is what we offer. 125 years of unrivalled expertise in supplying the world with what it needs most. We envision a world that runs entirely on renewable energy....
-
Banking Specialist
vor 5 Monaten
Duesseldorf, Deutschland Avaloq VollzeitCompany Description Founded and headquartered in Switzerland, Avaloq is continuously expanding its global footprint with around 2,500 colleagues in 10 countries, and more than 160 clients in 35 countries. We are an industry-leading provider of wealth management technology and services for financial institutions around the world, including private banks and...
-
Project Director
vor 6 Monaten
Duesseldorf, Deutschland Alimentiv VollzeitActs as the primary regional representative for the execution and delivery of clinical project(s); cultivate excellent Sponsor relationships, provide project oversight, assisting with project delivery services as required, ensuring that projects are adequately and appropriately staffed, meet sponsors quality, schedule, and budgetary requirements, that...
-
Banking Specialist
vor 5 Monaten
Duesseldorf, Deutschland Avaloq Vollzeit**Company Description** Founded and headquartered in Switzerland, Avaloq is continuously expanding its global footprint with around 2,500 colleagues in 12 countries, and more than 160 clients in 35 countries. We are an industry-leading provider of wealth management technology and services for financial institutions around the world, including private banks...