Regulatory Affairs Lead – Generics
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Remote
Location: Germany
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Job Level
About the role
- Lead and build the Regulatory Affairs team
- Develop and implement regulatory strategies
- Prepare, review and submit regulatory documentation
- Serve as primary contact for national and international regulatory authorities
- Support product development
- Review and ensure regulatory compliance
- Monitor post-marketing regulatory obligations
- Track regulatory changes and standards
- Work closely with cross-functional departments
Requirements
- Degree in a science or pharmaceutical discipline
- At least 5 years of professional experience in Regulatory Affairs within the pharmaceutical industry, preferably in generics
- Experience with EU drug approval procedures
- Strong understanding of global regulatory frameworks, particularly EMA, FDA and ISO
- Excellent written and verbal communication skills
- Analytical mindset with strong problem-solving skills
- Structured, detail-oriented work style and ability to manage multiple projects in parallel
- Proficient with regulatory submission tools and relevant software systems
- Fluent in German and English (business fluent)
Benefits
- An inclusive work environment with development opportunities
- Attractive salary and benefits package
- Highly flexible conditions with a 100% remote option (infrequent travel required)
- Opportunity to work on international, innovative projects with global reach
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory documentationregulatory complianceEU drug approval proceduresglobal regulatory frameworksEMAFDAISOregulatory submission toolspharmaceutical industry
Soft Skills
written communicationverbal communicationanalytical mindsetproblem-solvingdetail-orientedproject managementstructured work stylecross-functional collaboration