
Pharmaceutical Documentation Specialist
2 weeks ago
We are seeking an experienced professional to join our team as a CMC Supervisor. The successful candidate will be responsible for preparing Common Technical Documents (CTDs) and overseeing the implementation of EU regulations and ICH guidelines.
Key Responsibilities:
- Coordinate the compilation of CTD dossiers
- Supervise the implementation of EU regulations and ICH guidelines in the compilation of CTD dossiers
- Oversee CMC-wise projects under development
- Design regulatory strategies for dossier submission
- Coordinate responses to questions raised during product dossier assessments by authorities
- Collaborate with clients on documentation collection required for dossier submission
Requirements:
- Bachelor's degree in sciences, preferably Pharmacy or Chemistry
- Fluency in English, both written and oral
- Excellent computer literacy, specifically in MS Office
Preferred Qualifications:
- At least 5 years of experience in pharmaceutical companies, specifically in dossier compilation
- Multitasking abilities
- Able to meet deadlines
- Excellent teamwork skills
We offer a competitive salary, private insurance, and opportunities for personal development. If you are passionate about your work and want to make a difference in the pharmaceutical industry, apply now.
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