TRIGA Consulting GmbH & Co. KG

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

Compliance

• 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 Team Lead – Generics

• Strategic assessment and management of new regulatory approval projects, in-licensing initiatives and innovation programs
• Independent planning and execution of regulatory activities for new marketing authorizations in the EU and other regions
• Defining regulatory requirements in close coordination with internal regulatory teams and external partners
• Preparation, maintenance and coordination of regulatory dossiers, including eCTD
• Management of approval procedures as well as post-approval variations up to product launch
• Professional communication with regulatory authorities, including responses to deficiency letters
• Proactive advising of internal stakeholders on regulatory risks and strategies
• Active participation in strategy development, budgeting, compliance and process optimization

Regulatory Affairs Manager – Pharmaceuticals

• Umsetzung globaler regulatorischer Vorgaben auf nationaler Ebene in enger Abstimmung mit internationalen RA-Teams
• Erstellung, Prüfung und Pflege zulassungsrelevanter Dokumente
• Pflege von externen Portalen (z. B. Arzneimittellisten und Informationsservices)
• Begleitung von Artwork-Änderungen sowie Implementierung regulatorischer Updates über den gesamten Produktlebenszyklus
• Weiterbilden zu regulatorischen Entwicklungen und Kommunikation relevanter Informationen an interne Schnittstellen
• Sicherstellung einer nachvollziehbaren Dokumentation im Rahmen des bestehenden DMS

Regulatory Affairs Manager – Biosimilars

• Lead and further develop a regulatory team (approx. 10 employees)
• Responsible for the regulatory strategy of a product cluster across multiple markets
• Ensure regulatory compliance throughout the entire product lifecycle
• Represent Regulatory Affairs in company-wide, cross-functional projects
• Drive the development of processes and regulatory standards

Head of Regulatory Affairs – Pharma

• Strategic assessment and management of new regulatory approval projects, in-licensing initiatives and innovation programs
• Independent planning and execution of regulatory activities for new marketing authorizations in the EU and other regions
• Defining regulatory requirements in close coordination with internal regulatory teams and external partners
• Preparation, maintenance and coordination of regulatory submission dossiers, including eCTD
• Managing approval procedures and post-approval variations up to product launch
• Professional communication with regulatory authorities, including responding to deficiency letters
• Proactive advising of internal stakeholders on regulatory risks and strategies
• Active participation in strategy development, budgeting, compliance and process optimization