We are currently looking for Regulatory Affairs Manager to join the team.

The person will:

Ensure new registrations/line extensions according to BI strategy (full cycle);
Maintain existing Marketing Authorizations in RU by ensuring timely submissions of variations/renewals;
Communicate with Regional/Corporate RRA to ensure receipt of the relevant registration data and samples;
Maintain BI systems and databases in accordance with local responsibilities;
Ensure compliance of approved registration documents (ND, PIL, artworks) with marketed products;
Maintain of PSUR/DSUR/RMP management in accordance with local WI.

Our requirements:

Diploma Degree (Biopharmaceuticals, Biochemistry, Chemistry, Pharmacy);
Relevant Experience in RA (2 Years +);
High level of familiarity with the regulatory procedures;
Strong understanding of the company’s needs and ability to transform these into appropriate regulatory activities;
Advanced organizational, analytical, strategic skills with decision making capabilities;
Excellence at communication and negotiation;
English – Upper-Intermediate.

We offer:

Competitive salary
Social package: meal compensation, medical and life insurance, travel insurance
Professional and friendly team
Professional growth and development within stable global company

The vacancy is available for applicants with disability.

Boehringer Ingelheim is an equal opportunity employer. We are ready to consider all qualified applicants without regard to disability. The assessment how the requirements for the job are comparable to your personal characteristics is your own responsibility.

If you have what it takes to be successful in this role introduce yourself by submitting your resume.

Who we are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is our growth.