International Regulatory Affairs Specialist

**Site**: Berlin**Specialist field**: Regulatory Affairs**Career level**: Experienced professionals**Commencement date**: with immediate effect**Type of contract**: Fixed-term**Working time**: Full-timeWithin our International Regulatory Affairs & Drug Safety Department in Berlin, you will be responsible for the acquisition and regulatory management of international marketing authorisations of medicinal products, medical devices and food supplements. Based on your excellent knowledge and experience, you will conduct all necessary activities to acquire and maintain authorisations, registrations and certifications for our OTC products in different countries. As part of an international team you will be in close contact with colleagues in the countries, at our Regional headquarters in Berlin and other companies of the Menarini Group.

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 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
- First professional experience in the field of regulatory affairs in the pharmaceutical industry or at a relevant authority
- Regulatory knowledge in the area of OTC products, ideally in an international context
- Knowledge and understanding of the EU and non-EU pharmaceutical legislation
- Strong social skills in working with internal and external business partners
- Fluent English skills
- Very good knowledge of MS Office

What you can look forward to
- **Job & Private life**: regulated & flexible working hours at 38.5 hours/week, 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**: very good remuneration package according to the collective-bargaining agreements of the chemical industry, holiday and Christmas bonus, company pension allowance, 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, individual development opportunities at the professional and personal level
- ** Active participation & Collaboration**: challenging tasks in a leading-edge industrial sector, make a valuable contribution together to improving the quality of life of many people, 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

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin

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.