Director CMC Operations
Abarca HealthSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
Candidates should possess a Master’s degree or PhD in biotechnology, pharmaceutical sciences, or bio-engineering, with relevant expertise in CMC development and CMC regulatory affairs in China. Experience with large molecules is preferred, and strong scientific writing skills are essential.
Responsibilities
The Associate Director CMC China Dossier Development will lead the preparation of CMC documentation for China clinical and commercial dossiers, including conducting CDE consultation meetings, preparing scientific briefing documents, and regulatory response documents. The role involves overseeing life cycle management of China dossiers, assessing regulatory impact of CMC change controls, ensuring submission package completeness, coordinating with external partners, providing strategic input into CMC development, and tracking regulatory commitments.
Skills
CMC documentation
Regulatory interactions
CDE consultation
Life cycle management
Dossier development
Therapeutic drug development
Clinical development
Regulatory strategy
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees