TRIGA Consulting GmbH & Co. KG

Compliance

• Independent management of procedures in pharmaceutical drug approvals
• Preparation of regulatory submission documentation in eCTD format and submission to authorities
• Life-cycle management (renewals, variations)
• Direct contact with regulatory authorities and point of contact for internal and external RA inquiries
• Maintenance and optimization of the regulatory information database
• Drafting and reviewing product information texts

Regulatory Affairs Manager – Generics

• 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

• Independently manage procedures for medicinal product approvals
• Prepare regulatory submission documentation in eCTD format and submit it to the authorities
• Life-cycle management (renewals, variations)
• Direct contact with regulatory authorities and serve as a point of contact for internal and external Regulatory Affairs queries
• Maintain and optimize the regulatory information database
• Draft and review product information texts

• Responsibility for ensuring compliance with and implementation of the EU REACH Regulation
• Primary point of contact for all REACH-related matters within the corporate group
• Registration, maintenance and updating of substance and product dossiers in accordance with applicable regulations
• Advising internal departments on toxicological and ecotoxicological issues
• Monitoring legal changes in European chemicals legislation and deriving appropriate measures for the company
• Participation in professional events and industry networks to identify regulatory developments at an early stage
• Coordination of external partners and service providers to obtain registration-relevant data – including budget control and follow-up

Regulatory Affairs Manager – REACH

• Prepare and update technical documentation for medical devices in accordance with MDR 2017/745
• Ensure compliance with applicable regulatory requirements
• Develop test plans, organize testing activities, and define test parameters and equipment
• Create standardized test reports to demonstrate compliance with relevant standards
• Serve as the primary contact for notified bodies during technical documentation reviews and for regulatory inquiries from development and production teams
• Define regulatory strategies for the approval of medical devices

Regulatory Affairs Manager – Generics

Regulatory Affairs Manager – Generika

Regulatory Affairs Manager – Generics

Regulatory Affairs Manager – REACH

Regulatory Affairs Manager – Medical Device