Home United States Scientist, GRA CMC
Home United States Scientist, GRA CMC
Scientist, GRA CMC
at CSL Behring
in
United States
Posted on January 9, 2024
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 Scientist, GRA? The job can be located at Kankakee IL. This is a hybrid position. You will report to the AD, Team Lead of GRA. You will define and implement global and regional science-based registration strategies for our products enabling the organization to conduct all business activities, including in all developmental and commercial phases of a product's lifecycle. You will organize the preparation of registration dossiers enabling product approval and maintenance of product approvals globally. Establish relationships with regulatory agencies and other government authorities. Represent us in matters before regulatory, legislative, or industry standards agencies so our interests are advanced. Anticipate and analyze changes to the regulatory environment and partners with other organizationfunctions to generate strategic impact analysis of such changes and by providing the necessary tools to inform decision-making and provide organization with a competitive advantage. Responsibilities:
- Create and compile registration application documentation, including investigation of country specific authority requirements concerning layout, content and structure.
- License maintenance; inclusive of monitoring and submissions.
- Interface and communication with the regional offices in the context of registration projections.
- Regulatory system; data entry and maintenance in/of regulatory systems.
- Bachelor's degree in a Life Science
- 1+ years regulatory experience in the pharmaceutical industry.
- Medical, Dental Vision
- 401K
- Paid time Off
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!
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CSL Behring
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