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Senior Lead, Regulatory CMC
TRIGA Consulting GmbH & Co. KG. Develop and implement regulatory CMC strategies for assigned products .
About the role
Key responsibilities & impact- Develop and implement regulatory CMC strategies for assigned products
- Lead all product-related Regulatory CMC activities across the portfolio and ensure timely execution
- Prepare, review, and maintain CMC documentation for regulatory dossiers
- Develop the corresponding regulatory rationales
- Assess national and international requirements and ensure regulatory compliance
- Contribute to submission strategies
- Support changes to and further development of existing products
- Assess regulatory risks, particularly in connection with variation procedures
- Develop appropriate mitigation measures
- Work closely with internal departments, international partners, and external service providers
- Provide subject-matter guidance to colleagues
- Contribute to cross-functional improvement projects
Requirements
What you’ll need- Master’s degree in Pharmacy, Chemistry, Biology, or a comparable scientific discipline
- At least 7 years of professional experience in Regulatory CMC within the pharmaceutical industry
- Extensive experience with CMC dossiers, regulatory submissions, and the maintenance of approved medicinal products
- Strong knowledge of national and international regulatory requirements
- Experience providing functional leadership on complex projects and across interfaces
- Matrix or direct people-management experience is an advantage
- Strategic thinking
- Structured and self-directed approach to work
- Excellent communication skills when collaborating with internal departments and external partners
- Excellent German and English language skills
Benefits
Comp & perks- A responsible role offering significant scope to shape and influence within an international working environment
- Flexible working models with the option to work remotely
- Working-time account with time off in lieu
- 30 days of annual leave
- Individual internal and external training and development opportunities
- Flexibly usable additional benefits budget
- Access to an employee discount platform
- Company and team events