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CMC Regulatory Affairs Manager

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Sep 25, 2022

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Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time
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Job Details

Job Description

The Opportunity

We have an exciting opportunity for a Regulatory Affairs Manager, CMC & Compliance based at our Holly Springs site. Reporting to the Senior Manager, Regulatory Affairs Site Head, The RA manager, CMC & Compliance role is a technical strategic role within the CMC and Compliance Group. You will contribute to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist strategic advice and support to Project/Product teams, Quality Operations and Manufacturing Operations.

We have an exciting opportunity for a Regulatory Affairs Manager, CMC & Compliance based at our Holly Springs site. Reporting to the Senior Manager, Regulatory Affairs Site Head, The RA manager, CMC & Compliance role is a technical strategic role within the CMC and Compliance Group. The role contributes to the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist strategic advice and support to Project/Product teams, Quality Operations and Manufacturing Operations.

The Role
  • In association with colleagues ensure CMC dossiers meet content requirements for applicable territories
  • Lead the authoring, preparing and compiling of high quality, submission-ready CMC documentation for HA submissions in Seqirus Territories
  • Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes
  • Provide strategic regulatory expertise and guidance to develop technical protocols and reports (e.g. assay development, validation, stability, and product development)

Your skills and experience
  • A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Master's or PhD, or complementary experience in the pharmaceutical/ biotechnology industry
  • 7 years' regulatory experience with regulatory knowledge and experience in CMC.
  • You will have Project Management experience in the CMC world
  • Additional experience in a biologicals or biotechnology manufacturing environment e.g., QA or manufacturing or technical/product development is advantageous

We want Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

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

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