Regulatory CMC Manager

Bern, Canton of Bern, ch
Company: CSL Behring
Category: Management Occupations
Published on 2021-07-26 16:10:32
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring () is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma () , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.For our location in Bern (Switzerland), Marburg (Germany), Broadmeadows (Australia) or Kankakee (USA), we are looking for a**Global Regulatory Affairs CMC Manager (100%) (m/f/d)****Main Responsibilities and Accountabilities:**+ Change assessments in TrackWise for multisite biologic products including clarification with SMEs and confirmation with international countries.+ Assessing changes and supporting submission with CMOs.+ Revision of technical documentation (Risk Analysis, Cleaning Validation, Qualification Reports etc.).+ Annual Report for FDA/US and Annual Drug notification for Canada - support, submissions, document updates.+ Managing operational activities for the variation submissions (formatting and uploads of documents, maintaining trackers, QC of submission packages).+ Compliance check of 32A1 part of the dossiers.+ Maintaining information in submission tracking systems ().**Qualifications & Experience:**+ University Degree in natural sciences or bioengineering further education specialized in Regulatory Affairs would be an asset.+ Minimum 5 years' experience in biotech or pharmaceutical industry with a minimum of 3 years experience in Regulatory Affairs.+ Sound knowledge in natural or technical sciences with a focus on biological medicinal products.+ Basic knowledge of the regulatory framework in key regions (US, EU, Japan, CH, Australia).+ Fluent in English, local language skills would be a strong asset.We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. **Please include all these in one document together with the CV.**_CSL Behring is committed to provide equal employment opportunity for all._Worker Type:EmployeeWorker Sub Type:RegularR-138195 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://

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