Jobbeschreibung
BERLIN-CHEMIE AG belongs to Italy's Menarini Group and researches as well as develops pharmaceutical products, distributing them in more than 30 countries. Our dedication to health is what unites the many different staff at our company. With our responsible work, we make sure that patients can rely on us. For we stand for life.
Within our International Regulatory Affairs & Drug Safety Department in Berlin, you will be responsible for the acquisition and regulatory management of international marketing authorisations of pharmaceutical products. Based on your excellent knowledge and experience, you will conduct all necessary activities to maintain existing or acquire new authorisations, registrations and certifications for our products in the Eastern European and CIS countries. As part of an international team you will be in close contact with our local colleagues in the countries and report to the respective Group Regulatory Affairs Manager.
International Regulatory Affairs Manager (m/w/d)
- Site: Berlin
- Specialist field: Regulatory Affairs
- Career level: Experienced professionals
- Commencement date: with immediate effect
- Type of contract: Fixed-term
- Working time: Full-time
- Evaluating the required regulatory activities and preparing the respective documentation as well as submission schedules under consideration of local provisions and laws of the various countries
- Interacting with stakeholders and related departments to guarantee that all relevant activities are performed appropriately and in time
- Clarifying the necessary steps for acquiring and maintaining product authorisations, registrations and certifications with licensors and Berlin-Chemie AG representatives abroad as well as with the relevant organisations and authorities
- Preparing all regulatory activities in compliance with valid regulations and Best Practice guidelines
- Continuously monitoring and analysing all amendments to and updates of the relevant regulatory legislations, regulations and deadlines of the respective countries and acting as contact person for regulatory questions.
The offered position is limited for 2 years.
- University degree in pharmacy, chemistry or a comparable qualification in natural science
- Professional experience in the field of regulatory affairs in the pharmaceutical industry or at a relevant authority
- Extensive regulatory knowledge in the area of pharmaceutical products in an international context, ideally within the EAEU
- In depth knowledge and a thorough understanding of the EU and non-EU pharmaceutical legislation
- Strong social skills in working with internal and external business partners
- Fluent English skills, knowledge of the Russian language is an advantage
- Very good knowledge of MS Office
- Job & Private life: flexible working hours, up to 2 days mobile work/week, 30 days holiday, possibility of additional days off & individual solutions to improve the organisation of working hours in all phases of life
- Financials & Services: market- and performance-driven remuneration package comprising fixed salary and target-orientated bonus, holiday and Christmas bonus, company pension allowance, several insurance services, numerous discounts on the Corporate Benefits platform
- Mobility & Location: direct connection to local public transport, free parking spaces, bicycle stands, charging stations for e-vehicles
- Health & Prevention: fresh meals in the company restaurant and barista coffee with meal allowance, regular Days of Health, health check-ups and ergonomics advice in our company medical practice, sports courses and groups, support with childcare, nursing and mental health from an external service provider
- Onboarding & Development: two Welcome Days to get to know the company and network, structured induction process by experienced colleagues, professional onboarding and mentoring programme, regular feedback in performance reviews and target-setting meetings, individual further training and continuing education for professional and personal development
- Active participation & Collaboration:Make a contribution in a leading-edge industrial sector to the long-term further development of our innovative portfolio of medicinal products and treatment options, open and international working culture in a corporate setting with plenty of room for your own development and networking at the company
Diversity out of conviction
Diversity, equal opportunities and belonging are at the centre of our culture. We value the uniqueness and individual skills of all our colleagues. In this way, we create an environment in which we as a community benefit from diverse ideas, experiences, working methods, cultures and different realities of life. We also follow this guiding principle when recruiting and selecting new employees, as we are convinced that diversity makes our company more efficient and attractive.
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