Berlin & Homeoffice: Regulatory Affairs Manager (m/w/d) - Pharma at Triga Consulting GmbH & Co KG | Berlin | Rezi

Berlin & Homeoffice: Regulatory Affairs Manager (m/w/d) - Pharma at Triga Consulting GmbH & Co KG

Berlin & Homeoffice: Regulatory Affairs Manager (m/w/d) - Pharma

Triga Consulting GmbH & Co KG · Berlin

5 days ago

Berlin & Homeoffice: Regulatory Affairs Manager (m/w/d) - Pharma

Triga Consulting GmbH & Co KG · Berlin

5 days ago
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About the Role

Our client is an internationally operating pharmaceutical organization seeking an experienced Regulatory Affairs professional. This position offers broad regulatory responsibilities across the full product lifecycle within a collaborative international environment.

Responsibilities

  • Drive regulatory submissions across multiple international markets.
  • Prepare high-quality regulatory dossiers and lifecycle applications.
  • Review scientific documentation for submission readiness.
  • Ensure regulatory compliance throughout development activities.
  • Provide regulatory guidance to internal stakeholders.
  • Evaluate regulatory consequences of proposed product changes.
  • Update product labeling and regulatory documentation.
  • Handle authority questions and regulatory correspondence.
  • Support implementation of health authority commitments.
  • Collaborate with external partners and regulatory agencies.

Requirements

  • Scientific or pharmaceutical academic background.
  • Professional Regulatory Affairs experience.
  • Understanding of European regulatory procedures.
  • Strong organizational and planning skills.
  • Analytical mindset with attention to detail.
  • Experience using regulatory documentation systems.
  • Confident communicator across multidisciplinary teams.
  • Fluent German (C1) and English communication skills.
  • Willingness to travel occasionally.

Location

  • Berlin

Work Type

  • Hybrid working model
  • Homeoffice

Experience Level

  • Experienced professional

Education Level

  • Scientific or pharmaceutical academic background

Benefits

  • Hybrid working model with flexible scheduling.
  • Challenging international regulatory responsibilities.
  • Supportive leadership and collaborative colleagues.
  • Individual learning and career development.
  • Competitive compensation and comprehensive benefits.
  • Stable employer with long-term opportunities.

About the Company

  • Our client is an internationally operating pharmaceutical organization.