Regulatory Affairs Manager
Education: University degree in Pharmacy or Life science
Languages: Ukrainian – fluent; Upper-intermediate English as a business language
Experience: 3 years experience in Drug Regulatory Affairs
Core knowledge, competencies & skills:
Good knowledge and full understanding of pharmaceutical regulation, approval procedures, GMP certificates recognition requirements
Good oral and written communication skills
Effective time management skills
Experience in project management
Works effectively with IT solutions, including electronic team workspaces and internal databases
Personal Characteristics: Accountability, initiative, stress management, persistence, quick learning, result orientation, ability to work on one’s own.
Key Responsibilities:
Supports GMP certificates recognition procedure (e.g. inquire the dossier from the site, check the dossier materials, answer to inquiry from the expert, negotiate with the site, track and communicate approval status)
New submissions and maintenance of assigned procedures (e.g. variations, safety updates, renewals): coordinate, prepare and assure timely submission and approvals of dossiers for assigned registration procedures; track and communicate approval status perform tracking of deadlines, events and KPIs
Development of normative documents, instructions for use and artworks of drug products and following approval in relevant systems
Databases maintaining with up-to-date information
Observe strictly all applicable internal and external regulations, acts and procedures.
Comply with the GxP quality requirements applicable to his/her area of responsibility
Iryna Kshanovska
Novartis Pharma Services AG Перевірена
