29.03.24 | Vollzeit | München | JobLeads GmbH | 150.000 € - 200.000 € Leaders, regulators, and key consultants; S-A global research management Decision Making Authority •Ensure procedures and practices within therapeutic area or project group are consistent with departmental SOP and relevant external standards •Interpret the project implications of regulatory guidelines
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € • Partner with operation; work on the shop floor and in a team environment to provide on the spot input and guidance in responding to deviations. Lead investigation teams. • Make recommendations to department management regarding results of investigation and process improvements, when necessary. • Work
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € Function - Provide timely epidemiologic input into regulatory and risk management reports including PSURs, labeling, Safety Monitoring Plans, REMS - Enhanced Pharmacovigilance Plans and Health Authority, and Expert Statements, Health Authority requests - Provide timely epidemiological and risk management
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € Associate Director Global Regulatory Strategy (RP) - Full-time The primary responsibility of this role, as Associate Director Global Regulatory Strategy, is acts as the primary interface between this company and the local Health Authority. The successful candidate will •Possess an advanced
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € With operation; work on the shop floor and in a team environment to provide on the spot input and guidance in responding to deviations. Lead investigation teams. • Make recommendations to department management regarding results of investigation and process improvements, when necessary. • Work with impacted
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € And signal detection tools, i.e. EMPIRICA Prepares clinical expert statements and provides input in responses to inquiries from regulatory authorities or healthcare professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO
Später ansehen29.03.24 | Vollzeit | München | JobLeads GmbH | 150.000 € - 200.000 € Such as AAMI, IEC, ISO, UL. · Knowledge of Quality Management Systems (QMS) · Experience with working across cultures/countries/sites · Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. · Demonstrated understanding of healthcare
Später ansehen28.03.24 | Vollzeit | München | JobLeads GmbH | 100.000 € - 125.000 € Of their workgroup. · Travel to new manufacturing site as needed to support project. · All work must be done to comply with the Healthcare Quality System. · Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations. · Required to interact
Später ansehen28.03.24 | Vollzeit | München | JobLeads GmbH | 125.000 € - 150.000 € Progression of workflows providing copies of documentation to colleagues/contractors on request. - Maintains and tracks regulatory submission documentation (hard copy or electronic), including regulatory authority correspondence, in an appropriate document management system or hardcopy archive location
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