International Regulatory Affairs Manager (m/w/d)

Stellenbeschreibung

Take on responsibility for the future together with us.

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
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.

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

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Do you still have questions? We are happy to help!

// Ulf Kaiser
Human Resources Manager
+49 30 6707-2944

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.

Application process

* 1 //
Online- application
* 2 //
Selection
* 3 //
Job interview
* 4 //
Contract offer
* 5 //
Sending the contract documents
* 6 //
Onboarding
Berlin-Chemie AG | Glienicker Weg 125 | 12489 Berlin |
karriere.berlin-chemie.de

Kontakt

Berlin-Chemie AG