CMC-D Manager(m/w/x)

Beschreibung

As the Brand Lead for herbal products, you will drive CMC-D strategy and regulatory compliance. You'll balance technical authoring with leadership by coaching junior staff and optimizing functional processes.

Anforderungen

• •Desirable phyto-specific regulatory experience for Module 3
• •Degree in scientific field or international equivalent
• •Strong understanding of product development processes
• •Knowledge of ICH and quality-system guidelines
• •Familiarity with USP, Ph. Eur., and Pharmacopoeias
• •Understanding of regulations and industry standards
• •Strong understanding of cGMP and Quality Assurance
• •Analytical, problem-solving, and project management skills
• •Effective communication and cross-functional collaboration
• •Detail-orientation, accurate documentation, and teamwork
• •Proficient English communication skills

Aufgaben

• •Act as the Brand Lead for herbal Consumer Health Products
• •Manage CMC-D strategies for NPD and LCM projects
• •Apply specific herbal regulatory requirements to brand strategies
• •Author scientific briefing documents and complex TRDs
• •Draft responses to health authority questions
• •Approve TRDs for new product developments
• •Conduct CMC-D assessments for business due diligence
• •Manage CMC-D change impact assessments
• •Lead category continuous improvement initiatives
• •Provide coaching and training to junior colleagues
• •Manage relevant functional processes

Tools & Technologien

Benefits