Tirane, ofroj vend pune Regulatory
REQUIREMENTS FOR CANDIDATES
Position: Regulatory Affairs
• University degree (Faculty of Pharmacy or Medicine)
• Experience in the professional position of the associate.
• A high level of organizational, creativity and responsibility for fiduciary obligations.
• Knowledge of English language (written and spoken).
• Use of MS Office packet.
JOB DESCRIPTION:
• Preparation and submission to the National Agency of Medicine and Medical Devices the documents necessary for obtaining marketing authorizations for medicinal products and variation for existing products
• Observation of the established deadlines to remedy deficiencies and/or inconsistencies in the documentation submitted for registration of the respective medicinal product
• Follow up correspondences with Drug Agency
- Preparation and submission of documents for the documents necessary for registration of prices and the inclusion of medicinal products, for which a marketing authorization has been granted, in the Positive Drug List in accordance with legal requirements
- Formation of marginal or maximum price
- Creates, maintains and stores, the dossiers of each medicinal product of the company either electronically and/or in hard copy
EMPLOYEE’S BENEFITS
• Work in a positive, dynamic and stimulating environment.
• Continuous training and specialization.
• Good terms and conditions
Please send your CV with an accompanying letter until date 15.06.2021 to the link below:
https://zentiva.wd3.myworkdayjobs.c...vogen/RA---Pharmacovigilance-Manager_R2462271
Only shortlisted candidates will be contacted.