Life Science Research, Pharmaceutical
Poland
Posted 4 months ago
Location: Poland
4 days remotely/1 day office, Warsaw
Your Responsibilities:
- Manage and monitor regulatory activities for new products in line with project plans and timelines.
- Support lifecycle management of existing marketing authorizations, ensuring timely renewals and variations.
- Prepare and submit notifications and applications for dietary supplements, medical devices, and cosmetics to relevant authorities.
- Prepare registration documentation (CTD/eCTD) for new applications, renewals, and post-approval changes.
- Communicate with regulatory agencies and maintain regulatory databases (e.g., BPM).
- Respond to authority queries during registration processes in collaboration with internal departments.
- Ensure registration documents are up to date and properly archived.
- Coordinate expert reports, analyses, and additional documents required for registration.
- Stay up to date with EU and non-EU regulatory guidelines.
- Support in preparing basic data for registration strategy and budget planning.
- Perform audits of registration documentation.
- Carry out tasks assigned by the supervisor in a timely and diligent manner.
Our Requirements:
- Higher education in pharmacy, biotechnology, biology, chemistry, or related field.
- 2–3 years of experience in pharmaceutical product registration.
- Knowledge of EU and non-EU registration procedures for medicinal and non-medicinal products.
- Understanding of CTD and eCTD structure and content.
- Familiarity with pharmaceutical legislation and regulatory guidelines for drugs, medical devices, supplements, and cosmetics.
- Proficient in MS Office.
- Fluent Polish and English
