Regulatory Affairs Manager, CMC
Merz Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt am Main • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Apply knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products
- Create, review, and update high-quality CMC documentation to obtain and maintain product approvals
- Support the preparation of IMPDs for clinical trial applications
- Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
- Handle and manage inquiries related to quality documentation from regulatory authorities
- Oversee regulatory CMC projects and coordinate with Merz representatives and external partners
- Develop regulatory CMC strategies and represent regulatory requirements within project and interdisciplinary teams
- Maintain a detailed understanding of global and national CMC regulatory requirements and regulatory best practices
Requirements
- Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field; a doctorate is an advantage
- 3–5 years’ experience in regulatory affairs or in departments responsible for CMC matters such as analytics, development, or quality control
- Analytical and systematic thinking
- Strong negotiation skills and ability to work in teams
- Solution-oriented with a focus on compliance and quality
- Strong communication skills, including excellent command of English
Benefits
- Individual career development in a purposeful role: help improve the quality of life for our patients
- Hybrid working model that supports a good work–life balance
- Attractive location with good transport links, modern workspaces, and a company restaurant
- Global family-owned company with flat hierarchies and an open, respectful corporate culture
- Competitive compensation with comprehensive social benefits
- Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits, and JobBike
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC documentationIMPD preparationregulatory assessmentschange control processesregulatory CMC strategiesregulatory best practices
Soft skills
analytical thinkingsystematic thinkingnegotiation skillsteamworksolution-orientedcommunication skills
Certifications
PhD in PharmacyPhD in BiologyPhD in Chemistry