Support Regulatory Affairs - Bern, Schweiz - We make it

We make it

Geprüftes Unternehmen

Bern, Schweiz

vor 4 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Beschreibung:

We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for quality, ethics and discretion.

For our client, a renowned pharmaceutical company based in Bern, we are looking for a
Support Regulatory Affairs (f/m/d)

Support Regulatory Affairs (w/m/d):

Background
CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

Task and Responsibilites

Support GRA Region Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (nonEU)
Monitor local regulatory activities to ensure business objectives and timely implementation.
Be responsible for a specific submission package (new product/indication submission, variations, renewal) from preparation to submission in the region, by coordinating the preparation of the modules with the appropriate stakeholders.
Interact with Global Labelling relating to the labeling activities in the Region.
Support for the overall coordination and dispatch of responses to Health Authority questions, which include:
Preparing answers for simple questions not requiring product expertise or input from other internal stakeholders.
Supporting internal stakeholders for the strategy, planning and preparation of response for complex scientific questions requiring product expertise.

You must have these qualifications / Expierences

A degree in Biological or Medical Science or Pharmacy or equivalent
At least 3 years professional experience in Regulatory Affairs within international markets.
Good communication skills Fluent in English and any other language as Spanish, French, Arabic, Russian is an advantage.

Work hours