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)
Your 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.
What We’re Looking For
- 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.
Why Apply?
- 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
[email protected]
089-809130721
