Manager, Gra Cmc

Vor 4 Tagen

Bern, Schweiz CSL Behring Vollzeit

For our location in Bern, we are looking for a

**Global Regulatory Affairs CMC Manager (100%) (M/F/d)**

**Main Responsibilities and Accountabilities**:
- As a Change Control Expert, the position holder is accountable for the timely regulatory assessment of CMC changes, technical changes related to facility and equipment and/or plasma changes in the Global Change Control (GCC) system in accordance with global regulatory requirements and in close cooperation with GRA Regions. He/she is the first contact point for relevant local technical expert departments regarding regulatory questions related to change control, and may represent GRA in local and global change panels.
- The position holder may represent GRA in local change projects affecting multiple products or multiple sites worldwide. In this role he/she will coordinate and consolidate input from all relevant regulatory functions.
- As a Facility & Equipment Expert, the position holder is the primary GRA contact point interfacing with relevant technical expert departments for the compilation and maintenance of facility and equipment information for regulatory submissions.
- The position holder may represent Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment. Additionally, the position holder may serve as a designated GRA contact during GMP inspections and for preparation of inspections. He/she coordinates all incoming questions from an inspection within GRA.

**Qualifications & Experience**:

- University Degree in natural sciences or bioengineering further education specialized in Regulatory Affairs would be an asset.
- Minimum 1-3 years’ experience in biotech or pharmaceutical industry with a minimum of 1 year experience in Regulatory Affairs.
- Sound knowledge in natural or technical sciences with a focus on biological medicinal products would be an asset.
- Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
- Fluent in English

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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