Job Information
CSL Behring Manager, Regulatory Affairs in King of Prussia, Pennsylvania
Job Description
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 Manager of Global Regulatory Affairs? The job is located in the King of Prussia office. This is a hybrid position. You will report to the Regional Regulatory Therapeutic Area Director Lead.
Responsibilities:
You will plan, direct, and monitor regulatory affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce, sell, and distribute its goods and services.
Support development of roles and work processes.
Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.
Monitor regulatory developments and advise management on the potential impact of regulations on our company.
Establish relationships with government agencies and other regulatory authorities.
Represent us in matters before regulatory, legislative, or industry standards agencies so our interests are advanced.
Prepare materials for legal counsel or external consultants.
Create and compile of registration application documentation.
Regulatory system, data entry and maintenance in/of regulatory systems.
Qualifications:
Bachelor's degree in a Life Science or Business Advanced degree in a Life Science
3+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience advantageous
Experience with regulations, guidelines, and scientific principles; provide recommendations to supervisor, manages a project or staff with minimal supervision
BENEFITS
Medical, Dental Vision
401K
Paid time Off
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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 (https://www.cslbenefits.com/csl/candidates) 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 (https://www.cslbehring.com/our-company) .
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 (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.
Do work that matters at CSL Behring!
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement