GRA GPS, Global Regulatory Lead, TA Hematology

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jun 10, 2021
Ref
R-133387
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven 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 and Seqirus. 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. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Responsibilities:
• Manage, design and execute regulatory strategies for product portfolio expansion via potential License Applications (New Drug Submissions) and Life Cycle Management Submissions.
• Responsible for providing guidance and overseeing all regulatory activities in support of timely submissions to ensure there are no interruptions in supply;
• Ensure timely regulatory reports, communications and meetings with Regulatory authorities.
• Represent organization with Regulatory authority.

Qualifications:
• Advanced degree in Life Science or Business (Bachelor, Master, PhD, MBA).
• 8+ years regulatory experience in the pharmaceutical industry, Biologics Regulatory experience preferred.