International Regulatory Affairs Specialist
vor 4 Wochen
We are seeking a highly skilled International Regulatory Affairs Manager to join our team at Berlin-Chemie AG. As a key member of our International Regulatory Affairs & Drug Safety Department, you will be responsible for the acquisition and regulatory management of international marketing authorisations of pharmaceutical products.
Key Responsibilities- Evaluate regulatory activities and prepare documentation and submission schedules in accordance with local provisions and laws.
- Interact with stakeholders and departments to ensure timely completion of activities.
- Clarify necessary steps for acquiring and maintaining product authorisations, registrations, and certifications with licensors and Berlin-Chemie AG representatives abroad.
- Prepare regulatory activities in compliance with valid regulations and Best Practice guidelines.
- Monitor and analyse regulatory legislations, regulations, and deadlines of respective countries.
- University degree in pharmacy, chemistry, or a comparable qualification in natural science.
- Professional experience in regulatory affairs in the pharmaceutical industry or at a relevant authority.
- Extensive regulatory knowledge in the area of pharmaceutical products in an international context.
- Strong social skills in working with internal and external business partners.
- Fluent English skills, knowledge of the Russian language is an advantage.
- Flexible working hours, up to 2 days mobile work/week, 30 days holiday, and possibility of additional days off.
- Market- and performance-driven remuneration package, holiday and Christmas bonus, company pension allowance, and several insurance services.
- Direct connection to local public transport, free parking spaces, bicycle stands, and charging stations for e-vehicles.
- Fresh meals in the company restaurant and barista coffee with meal allowance, regular Days of Health, health check-ups, and ergonomics advice.
At Berlin-Chemie AG, we value diversity, equal opportunities, and belonging. We create an environment where diverse ideas, experiences, working methods, cultures, and different realities of life are valued. We follow this guiding principle when recruiting and selecting new employees, as we believe that diversity makes our company more efficient and attractive.
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