Job Description
Lavipharm is seeking a Senior Specialist Regulatory Affairs CMC who will be accountable for ensuring the appropriate licensing and maintenance of assigned products and development projects in line with company business objectives, relevant CMC regulatory requirements and internal and external standards.
Job Responsibilities
The ideal candidate will:
- Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Implement regulatory affairs policies and procedures to ensure that regulator...