**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). All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.