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Global Regulatory Affairs, CMC Manager

Employer
CSL Behring
Location
King of Prussia, PA
Start date
Feb 26, 2024

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Job Details

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor. 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.

Could you be our next Global Regulatory Affairs, CMC Manager? This position is located in our King of Prussia PA or Bern Switzerland office. It is a Hybrid role. You will report to the Associate Director of Global Regulatory Affairs.

As CMC Manager, Global Regulatory Affairs, you will be responsible for Chemistry, Manufacturing and Controls (CMC) regulatory activities related to product registration in international markets and license maintenance for assigned products of the Cell and Gene Therapy (CGT) portfolio.

Your responsibilities:

  • You will be responsible for development of global CMC regulatory strategies for product changes and CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.

  • Global Regulatory Affairs CMC contact point working with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions.

  • Oversee scheduling and prioritization of CMC regulatory submissions for assigned projects.

  • Coordination, compilation and review of regulatory CMC documentation (Module 2.3, Module 3 including Information Amendments, Briefing Books) and related documents for CMC submissions according to agreed timelines and taking regional regulatory requirements into account.

  • Maintain the relevant parts of the regulatory dossiers.

  • Interpret our regulatory requirements, evaluation of draft guidelines.

  • Evaluate available technical and scientific CMC information for compliance with regulatory requirements, performance of gap analyses and proposal of solutions and strategies to remediate risks.

  • Ensure integration of regional regulatory requirements, documentation and proactive adaptation of strategies to ensure incorporation of new information and start-of-the-art regulatory.

  • Provision of and compliant regulatory assessments and efficient execution of CMC change.

Your profile:

  • Bachelor's degree in biochemistry, chemistry, biology or related pharmaceutical fields (Bachelor, Master of Sciences or equivalent)

  • 5+ years' experience in the biotech/biopharmaceutical industry with at least 3 years relevant regulatory CMC experience with biologics and CGT for post-approval regulatory dossier life-cycle management and clinical development.

Benefits

  • Medical, Dental, Vision

  • 401k

  • PTO

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization 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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