Regulatory Affairs Specialist

Responsibilities

•    Responsibility for the registration and maintenance of Marketing Authorization for human medicinal products registered in Poland.
•    Execute strategy for new submissions in the country and ensure timely and successful submissions.
•    Ensure product maintenance in line with local requirements and global standards.
•    Cooperate with global and regional RA on concepts/strategies/projects.
•    Regulatory Intelligence: Foster close relationships with relevant Authorities and other key stakeholders.
•    Communication & impact assessment on new requirements.
•    Maintain allocated databases.
•    Ensure adherence to compliance rules as well as to relevant legislations in allocated areas of Regulatory Affairs.
•    Constant tracking of all compliance parameters for allocated products and processes (KPls).

Requirements

•    University life sciences degree 
•    Knowledge of local and EU regulatory affairs regulations
•    Relevant experience in pharmaceutical industry at least 2 years
•    English – at least B2
•    Knowledge of eCTD structure is an asset

What we offer

•    Employment contract with NDG company with work in Boehringer Ingelheim
•    Remuneration adequate to the level of experience and competence
•    Phone, laptop
•    Opportunities for improvement and professional development
•    Package of non-salary benefits (medical care, life insurance, Multisport card, My Benefit cafeteria, Employee referral program, Training and educational platforms, Holiday Allowance).