Senior Manager, CMC Regulatory Project Manager
- Employer
- CSL Behring
- Location
- Holly Springs, North Carolina
- Start date
- Mar 16, 2023
View more
- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
The Opportunity
We have an exciting opportunity for a Regulatory Project 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)
- 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
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
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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