International Regulatory Affairs Manager (m/w/d)

at  Berlin Chemie Menarini

Site: Berlin
Specialist field: Regulatory Affairs
Career level: Experienced professionals
Commencement date: with immediate effect
Type of contract: Fixed-term
Working time: Full-time
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.

These tasks inspire you

• 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.

What sets you apart

• 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

Have we aroused your interest? Then we look forward to receiving your informative online application stating your earliest possible starting date and salary requirements.

What you can look forward to

• 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

Do you still have questions?
We are happy to help!
// Ulf Kaiser
Human Resources Manager
+49 30 6707-2944
Vielfalt aus Überzeugung
Bei uns stehen Vielfalt, Chancengleichheit und Zugehörigkeit im Fokus unserer Kultur. Wir schätzen die Einzigartigkeit und individuellen Fähigkeiten aller Kolleginnen und Kollegen. So schaffen wir ein Umfeld, in dem wir als Gemeinschaft von vielfältigen Gedanken, Erfahrungen, Arbeitsweisen, Kulturen und unterschiedlichen Lebensrealitäten profitieren. Diesem Leitgedanken folgen wir auch bei der Rekrutierung und Auswahl von neuen Mitarbeiterinnen und Mitarbeitern, da wir davon überzeugt sind, dass Vielfalt unser Unternehmen leistungsfähiger und attraktiver macht

• 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