Egészségügy, gyógyszeripar állások, munkák a The Stepstone Group EMEA GmbH-nél

In this role, you will take the lead in developing Pharmaceutical Drug Products (New Chemical Entities - NCE), guiding the process from lead candidate selection through formulation and process development to the manufacturing of clinical trial materials. Additionally, you will support packaging...

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

as part of DFG sponsored project beginning in January 2026 limited for three years. The Title of the project is: EFFECTS OF LACTOBACILLUS REUTERI DSM 17938 ON THE ACUTE PSYCHOLOGICAL, ENDOCRINE AND IMMUNOLOGICAL STRESS RESPONSE IN HEALTHY CITY DWELLERS. Both preclinical and clinical data support...

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Lead and manage client relationships for pharma and biotech accounts, ensuring satisfaction and longterm partnerships
• Serve as product owner or strategic advisor on key market access projects (AMNOG, EU HTA, pricing, reimbursement)

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Coordination of the (partial) project to establish and continuously expand the EU reference network with all participating centres and clinics at EU level
• Participation in the helpdesk for the network's eHealth service
• Work with the project management team on the progression of the clinical registry

lead the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and company standards...

Strategic Influence: Shape the success of the TRICARE Overseas Program by building and nurturing high-level relationships with military and civilian partners....

• identify, target, and develop new business opportunities with hospitals, clinics, diagnostic centers, and healthcare groups across the GCC
• increase the share of wallet within strategic accounts by promoting and expanding the existing product portfolio

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Operation of a suite of on-line mass spectrometers (ToF-ACSM-X, VOCUS-PTR-MS) and further instrumentation to measure atmospheric composition in the gas and particle phases.
• Operation of offline instrumentation such as filter samplers and cloud water collectors during dedicated campaigns.

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• Leading the development of the faculty's research strategy and building a strong interdisciplinary team.
• Establishing translational research projects within SFU MED and in collaboration with national and international partners.

Act as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Change Control and Risk Management within the EUCAN region....

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.

Serving existing and new OEM customers as a reliable first point of contact, source of information and initial technical consultant, thereby bringing customer relationships to the next level....

• Provide organizational and administrative support to the Senior Commercial Director in daily operations
• Coordinate appointments, meetings, and travel arrangements
• Manage communication with internal and external stakeholders, especially healthcare professionals (HCPs)

• Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
• Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs