Regulatory Affairs Specialist
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!
Responsible for the coordination and preparation of document packages for regulatory submissions for plasma centers, PLCs, and Laboratory to regulatory authorities and customers, including Donor Adverse Events (DAEs) to proper authorities. Administers the county, state, federal licenses, registrations, and permits for all company sites.
1 Responsible for tracking and timely renewal of all CLIA, City, County, State, Federal licenses, registrations, and permits for all plasma centers, PLCs, and Laboratory. Distributes and maintains these records as necessary.
2 Responsible for the timely submission of GHA Site Master File (SMFs) prior to scheduled inspections. Requires coordination with Centers, Plasma Operations, Quality, PLCs, and Laboratory to obtain, distribute, and store applicable records.
3 Provides plasma centers with site-specific CLIA and State completed forms; Viral Marker and Lookback data in preparation for scheduled audits.
4 Monitors and tracks the scheduling and completion of external audits. Track and distribute audit inspection reports and responses to internal and external customers, as well as US and foreign regulatory agencies.
5 Creates and distributes monthly status reports regarding all inspections, certification, and approval status.
6 Prepares and submits annual proficiency testing renewals for all plasma collection centers, including off-cycle orders.
7 Responsible for the submission of reportable Donor Adverse Events (DAE) for plasma centers as required by regulation.
8 Review Center Managers’ documentation for completion and issue Regulatory approval letters.
9 Establishes and maintains relationships with regulatory agencies and trade associations to ensure continuous compliance with required certifications.
10 Responsible for completing and submitting documentation to notify CLIA and State agencies of Center Manager and Center Laboratory Director changes.
11 Assist with data collection and analysis in support of routine reports, KPIs and special projects.
12 May act as Notary Public for licensing, renewal applications, and other company documents as needed.
13 Other duties as needed or perform other job-related duties as assigned.
Associates Degree or equivalent combination of relevant work experience and education required
Minimum 1 year experience in related industry within a Regulatory Affairs or QA capacity preferred
(physical & mental requirements)
Shares information with internal and external contacts with common desire to reach a solution
Ability to complete routine forms or conduct routing oral communications
Ability to compose letters, outlines, memorandum and basic reports and/or to orally communicate technical information
Overtime and working extended hours may be required
Fast paced environment with frequent interruptions
Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.