TRIGA Consulting GmbH & Co. KG

Compliance

• Eigenverantwortliche Betreuung der Verfahren in der Arzneimittelzulassung
• Die Zulassungsdokumentation im eCTD-Format und deren Einreichung bei den Behörden
• Life-Cycle-Management (Renewals, Variations)
• Direkter Kontakt mit Zulassungsbehörden sowie Ansprechpartner für interne und externe RA Fragestellungen
• Betreuung und Optimierung der regulatorischen Informations-Datenbank
• Erstellen und Prüfen von Produktinformationstexten

Regulatory Affairs Manager – Generika

Manager

• Create, maintain and further develop guidelines for validation management, including qualification, process, computer and method validation
• Perform technical review, approval and support of validation activities in development and production
• Train employees on validation-related topics
• Conduct internal audits and actively support inspections and audits as a subject matter expert
• Contribute to CAPA management, including initiating, implementing and tracking corrective and preventive actions

Validation Manager – Medical Technology

• Lead and build the Regulatory Affairs team
• Develop and implement regulatory strategies
• Prepare, review and submit regulatory documentation
• Serve as primary contact for national and international regulatory authorities
• Support product development
• Review and ensure regulatory compliance
• Monitor post-marketing regulatory obligations
• Track regulatory changes and standards
• Work closely with cross-functional departments

Regulatory Affairs Lead – Generics

• Develop, maintain and advance validation management policies and procedures, including qualification, process validation, computerized system validation (CSV) and method validation
• Technically review, approve and support validation activities in development and production
• Train employees on validation-related topics
• Conduct internal audits and actively support inspections and external audits as a subject-matter expert
• Participate in CAPA management, including initiating, implementing and tracking corrective and preventive actions (CAPA)

Validation Manager – Medical Devices

• Lead and build the Regulatory Affairs team; initially responsible for one Regulatory Affairs employee
• Develop and implement regulatory strategies to ensure compliance with national and international regulations (e.g., EMA, BfArM, etc.)
• Prepare, review, and submit regulatory documentation such as product dossiers, marketing authorization applications, variations, and renewals to the competent authorities
• Serve as the primary point of contact for national and international regulatory authorities
• Respond to authority queries, organize and attend meetings, and ensure timely feedback and communication
• Provide regulatory advice during product development
• Ensure that new products meet all relevant regulatory requirements
• Review and ensure regulatory compliance of product labeling, promotional and advertising materials, and clinical documentation
• Monitor post-marketing regulatory obligations, including adverse event reporting and product recalls
• Monitor regulatory changes and standards and communicate relevant updates to internal stakeholders
• Collaborate closely with Quality Assurance, Research & Development, Manufacturing, and other departments

Regulatory Affairs Manager – Generika

Validation Manager – Medical Technology

Regulatory Affairs Lead – Generics

Validation Manager – Medical Devices

Regulatory Affairs Team Lead – Generics