International Regulatory Affairs Manager

Site: Berlin

Specialist field: Regulatory Affairs

Career level: Experienced professionals

Entry level: with immediate effect

Contract: fixed-term

Working time: Full-time

Homeoffice: hybrid work

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 until 31/07/2027.

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: 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: varied tasks in a leading-edge industrial sector, open and international working culture with room for your own development and networking at the company

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Do you still have questions?

We are happy to help

// Ulf Kaiser

Human Resources Manager

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin