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This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the...
This position provides strategic oversight of PV quality systems, audits, and inspections while ensuring compliance with global and regional regulatory requirements. The individual...
Provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs...
This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase...
You will oversee data management activities associated with clinical drug development for all clinical trials in Ascendis’ rare endocrinology portfolio. Furthermore, the duties...
Responsible for ensuring compliance with global regulatory requirements, development of compliance reports/metrics and implementation of corrective/preventative actions to address...
The role will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a...
Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities; Ensure Santhera meets its obligations as a...
Responsible for providing operational support for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within...
Leading the Clinical Pharmacology program and strategy of assigned programs by defining and implementing the Clinical Pharmacology Plan of NCE/NBE to support the registration...
Lead (Co-lead) the study teams to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings....
A managerial position responsible to ensure that assigned Quality Management System activities are managed in compliance with regulations and company policies and in accordance...
The core responsibility of the Medical Director is to lead the local medical department, be a part of pan-European R&D projects and work closely with other medical departments in...