Team Lead, Regulatory CMC Writing
Merz Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt am Main • 🇩🇪 Germany
Visit company websiteJob Level
Senior
About the role
- Primary point of contact for the manufacturing site for the preparation and maintenance of regulatory documentation to support the compilation of regulatory dossiers
- Preparation of CMC documentation in accordance with internal requirements and in collaboration with the manufacturing organization
- Supervision of a Regulatory CMC Writing Manager including coaching, performance evaluation, ensuring compliance, and monitoring and driving performance improvement
- Review of draft documents with CMC Regulatory Affairs (CMC RA) and the respective site
- Conducting initial impact assessments and ensuring documented justification for changes
- Providing documentation in accordance with the LoQ (level of quality) and timelines, and coordinating related tasks with the manufacturing site
- Defining and coordinating the required information and documentation with the manufacturing site and contractors to meet established regulatory deadlines
- Supporting GMP inspections as needed
- Staying current with global CMC regulations and best practices
Requirements
- Completed scientific degree in Pharmacy, Biology, Chemistry, or a related field; a PhD is an advantage
- 3–5 years of professional experience in pharmaceutical regulatory affairs, particularly with technical writing for Module 3
- Strong communication and problem-solving skills, with analytical thinking
- Team player who is results-oriented and persistent
- Solution-oriented with a focus on compliance and quality
- Fluent English; German is an advantage
Benefits
- Individual career development in a meaningful role: you contribute to improving patients' quality of life!
- Hybrid model enabling a good work–life balance
- Attractive location with good transport links, modern workspaces, and a company canteen
- Global family-owned company with flat hierarchies and an open, respectful corporate culture
- Attractive compensation with comprehensive benefits
- A range of employer-supported benefits such as WellPass, the Germany public-transport ticket (Deutschlandticket), Corporate Benefits, and JobBike
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentationCMC documentationtechnical writingimpact assessmentsGMP inspectionscompliancequality assuranceperformance evaluationcoachingdocumentation justification
Soft skills
communicationproblem-solvinganalytical thinkingteam playerresults-orientedpersistentsolution-orientedfocus on compliancefocus on quality
Certifications
PhD in PharmacyPhD in BiologyPhD in Chemistry