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Global Regulatory Affairs CMC Manager (100%) in the Albumins Team

Employer
CSL Behring
Location
Kankakee, IL
Start date
Feb 27, 2024

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

For our Global Regulatory Affairs department, we are currently looking for a :

Global Regulatory Affairs CMC Manager (100%) in the Albumins Team

Do you want to work in a global team and support worldwide registrations for Albumins?

The Global Regulatory Affairs CMC Scientist/Manager is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The role will collaborate globally with internal and external stakeholders and includes the commitment to continuous improvement and tight collaboration. The role reports to the Global Regulatory Affairs CMC Albumins Lead.

The Role

  • Develops and executes global regulatory strategies in close collaboration with the site Quality and Manufacturing Departments and with regional regulatory experts to license product changes.
  • Develops and executes global regulatory strategies to obtain new marketing authorizations worldwide of established product in agreement with the commercial organization.
  • Represents the Global Regulatory Affairs function in cross-functional project teams.
  • Responsible for the maintenance of the content of regulatory submissions of the licensed products from the site of manufacture, meeting appropriate standards and content requirements.
  • Responsible for the compilation of relevant high-quality documentation for CMC submissions according to agreed schedules while taking into account regional specific requirements.
  • Authors the CMC dossier narratives for the comprehensive CTDs.
  • Coordinates the compilation and updates of technical documentation with expert departments.
  • Compiles CMC documentation in preparation of Scientific Advice Meetings, contributes to and participates at Scientific Advice Meetings.
  • Evaluates the CMC technical and scientific information for compliance with regulatory requirements, identifies deficiencies and proposes strategies to remediate risks.
  • Compiles the CMC part of Base Dossiers for new marketing authorization applications in relevant countries.

Your Skills and Experience

  • Bachelor or master’s degree in natural science, medicine or paramedicine from University or Applied University (FH)
  • Minimum 1 year of experience in the pharmaceutical industry, sound knowledge of the global regulatory environment
  • Strong background in natural sciences with a focus on biological medicinal products
  • Excellent communication, project management, planning, problem solving and presentation skills.
  • Ability to work with minimal supervision, with sound technical judgment and analytical skills.
  • Flexibility to work in a global regulatory cross cultural work environment and can work independently as well as in a team.
  • Fluent in English, German is a plus.

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.

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!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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