Leipzig + Homeoffice: Regulatory Affairs Manager (m/w/d) - Pharma

The Opportunity

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.

Regulatory Affairs Manager (m/f/d)
Location: Leipzig (in combination with homeoffice)

• 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.

• 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.

• 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.

Contact:

Silvio Di Meglio
CEO TRIGA Consulting
089-809130721