Regulatory Affairs Manager – Europe, Pharma

TRIGA Consulting GmbH & Co. KG

. Develop regulatory strategies for European markets and support compliant market access .

Posted 11/6/2026full-timeLeipzig • GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong understanding of European regulatory frameworks, product lifecycle requirements, and compliance solutions. Proficient in engaging with authorities and cross-functional teams while delivering regulatory assessments and training.

Highest-signal resume keywords

Regulatory Affairs ExperienceEuropean Regulatory FrameworksGMP and GDP KnowledgeFluent German (C1)Fluent English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentProduct Lifecycle ManagementRegulatory AssessmentsCompliance SolutionsRegulatory Risk Identification

Soft Skills

Clear CommunicationCross-Functional Relationship BuildingPrioritizationTraining Delivery

Industry Keywords

Market AccessProduct RegistrationAudits and InspectionsAuthority EngagementQuality Expectations

About the role

Key responsibilities & impact

Develop regulatory strategies for European markets and support compliant market access
Assess regulatory requirements for products and services entering Europe from international markets
Guide product launches, registrations, variations, and lifecycle activities across relevant jurisdictions
Interpret evolving legislation and translate requirements into practical business actions
Advise commercial, quality, and operational teams on regulatory questions throughout product lifecycles
Coordinate with international regulatory colleagues to align regional approaches and share expertise
Engage with authorities, notified bodies, external consultants, and other relevant partners
Prepare regulatory assessments and recommendations within demanding business timelines
Support audits, inspections, authority requests, and related follow-up activities
Identify regulatory risks and opportunities and develop pragmatic compliance solutions
Deliver internal training and improve regulatory processes, standards, and awareness

Requirements

What you’ll need

Relevant degree
Substantial experience in Regulatory Affairs
Understanding of European regulatory frameworks
Understanding of product lifecycle requirements
Knowledge of GMP and GDP quality expectations
Ability to own complex topics and set priorities
Ability to explain regulatory matters clearly
Fluent German (C1)
Fluent English
Ability to build productive cross-functional relationships
Willingness and ability to attend the office in Saxony regularly
Ability to travel to in-person meetings when required

Benefits

Comp & perks

Unbefristeter Arbeitsvertrag
6-month probation period
40 hours/week
30 days annual leave
Attractive compensation package
Well-being support
Collaborative working environment
Direct communication and room to contribute
Remote work arrangement with regular office attendance