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Senior Lead Regulatory CMC
TRIGA Consulting GmbH & Co. KG. Develop and implement regulatory CMC strategies for assigned products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and implementing Regulatory CMC strategies, managing CMC documentation, and ensuring compliance with national and international regulatory requirements. Proficient in providing technical leadership and collaborating effectively with cross-functional teams and external partners.
Highest-signal resume keywords
Regulatory CMC StrategiesCMC DossiersRegulatory SubmissionsTechnical LeadershipGerman Language Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory ComplianceLifecycle ManagementRegulatory JustificationsRisk AssessmentMitigation Measures
Soft Skills
Strategic ThinkingStrong Communication SkillsStructured Working Style
Certifications & Qualifications
Master’s Degree in PharmacyMaster’s Degree in ChemistryMaster’s Degree in Biology
Industry Keywords
Pharmaceutical IndustryCross-Functional Improvement ProjectsMatrix ManagementInternational Regulatory Requirements
About the role
Key responsibilities & impact- Develop and implement regulatory CMC strategies for assigned products
- Manage all product-related Regulatory CMC activities across the portfolio and ensure timely execution
- Prepare, review, and maintain CMC documentation for regulatory dossiers, including the development of corresponding regulatory justifications
- Assess national and international requirements and ensure regulatory compliance
- Contribute to submission strategies and support changes and further development of existing products
- Assess regulatory risks, particularly in connection with variation procedures, and develop appropriate mitigation measures
- Work closely with internal departments, international partners, and external service providers
- Provide technical guidance to colleagues and contribute to cross-functional improvement projects
Requirements
What you’ll need- Completed 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 lifecycle management of authorized medicinal products
- Proficiency in handling national and international regulatory requirements
- Experience providing technical leadership for complex projects and cross-functional interfaces
- Matrix or direct people-management experience is an advantage
- Strategic thinking combined with a structured and autonomous working style
- Strong communication skills when collaborating with internal departments and external partners
- Excellent German and English language skills
Benefits
Comp & perks- A responsible position with scope to shape processes in 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
- A flexibly usable additional benefits budget
- Access to an employee discounts platform
- Company and team events