Jr. Regulatory Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Qualifications
- Bachelor’s degree in chemistry and chemical engineering departments,
- Knowledge of CMC and documentation activities, change management,
- Able to use MS Office programs effectively,
- Good level of English verbally and in writing,
- Excellent planning, organization and time management skills.
Job Description
- Ensuring the regulatory compliance of registered information in the operation,
- Prepare Module 3 CMC part of dossier for Sanofi products, the variations and MA renewal dossiers for registered products, management of deficiency letters,
- Participation on the Change Control process and management of Change control procedures (initiated from regulatory reasons), responsibility for the registration part of a realization for all Change control procedures,
- Transferring information about approved registration documents to all involved departments within company,
- To monitor update European Pharmacopoeia and to perform relevant studies.
