Global Regulatory CMC Manager

We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector 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 make it GmbH places the highest demands on quality, ethics and discretion.

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

Global Regulatory CMC Manager

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.

For our impurity and data management (IDM) team within plasma and product development (PPD) departmentin Bern we are looking for a Global Regulatory CMC Manager (f/m/d).

Tasks

• Knowledge about CSL s products is an asset
• Minimum 5 years experience of working with electronic Common Technical Documents (eCTD)
• Knowledge about change assessment and process for change controls (Trackwise)
• Ability to handle high complexity and display it in a simple and clear way
• Flexibility to work in a global regulatory cross cultural work environment and ability to work independentlyas well as in a team
• Ability to work with minimal supervision, with sound technical judgment, analytical skills and criticalthinking

Requirements

• 10 years of experience in the pharmaceutical industry
• Strong background in natural sciences with a focus on biological medicinal products, ideally plasma-derivedproducts
• Team player with good verbal and writing communication skills in German and English and able towork in interdisciplinary teams.
• Fluent in English, German is a plus.

Work hours

• 8 - 16 h./ Week / Hybrid work (remote and on site)

Then Mr. Andre Amstad is looking forward to receiving your complete application documents (CV, copy of your work references and your educational certificates).