Strategic Regulatory Affairs Lead, Europe (Remote)

Triga Consulting GmbH & Co KG; United States; Hybrid; USD 101.000 - 146.000; Vollzeit

Zusammenfassung

Triga Consulting GmbH & Co KG in Germany is seeking an experienced Regulatory Affairs Manager to oversee European regulatory activities from a remote base with periodic visits to the Leipzig area. The role blends strategic regulatory guidance with hands-on work across a diverse product portfolio.

You will develop regulatory strategies for Europe, manage product lifecycle activities, coordinate with authorities and partners, and support audits and inspections while training teams on compliance

Qualifikationen

• Experience in Regulatory Affairs within Europe.
• Understanding of European regulatory frameworks and product lifecycle requirements.
• Familiarity with GMP and GDP expectations.
• Ability to communicate regulatory matters clearly across functions.

Aufgaben

• Develop regulatory strategies for European markets and support compliant market access.
• Assess regulatory requirements for products entering Europe from international markets.
• Guide launches, registrations, variations, and lifecycle activities across jurisdictions.
• Interpret evolving legislation and translate requirements into practical actions.
• Advise cross-functional teams on regulatory questions throughout lifecycles.
• Coordinate with international regulatory colleagues to align approaches.

Kenntnisse

Regulatory Affairs

European Regulations

GMP/GDP knowledge

Stakeholder communication

Ausbildung

Relevant degree

Jobbeschreibung

Triga Consulting GmbH & Co KG in Germany is seeking an experienced Regulatory Affairs Manager to oversee European regulatory activities from a remote base with periodic visits to the Leipzig area. The role blends strategic regulatory guidance with hands-on work across a diverse product portfolio.

You will develop regulatory strategies for Europe, manage product lifecycle activities, coordinate with authorities and partners, and support audits and inspections while training teams on compliance