GRA CMC Specialist
Employment type
Full-time
Work setting
On-site
Location
King of Prussia, PA
Schedule
Day shift
Posted
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Job overview
The GRA CMC Specialist is an onsite role based in King of Prussia, PA. Compensation is not specified for this position, which supports the CSL Global Regulatory Affairs team. This role exists to partner with R&D, manufacturing, and quality stakeholders to address regulatory strategy challenges for biological and non-biological products. The specialist defines global regulatory strategies and represents CSL in interactions with regulatory agencies.
What you'll do
- Lead global regulatory CMC strategy
- manage CMC regulatory submissions
- perform change control assessments
- represent CSL in regulatory interactions
- provide regulatory consultation to internal functions
- support policy development.
What we're looking for
- Skills & competencies
- full-timeonsiteking of prussia pacslregulatory affairscmcbiologicscomplianceno on-callleadership
- Work arrangement
- Weekend coverage required
Why this role
5+ years of experience in biologics or plasma industry.
About the employer
CSL is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.
Additional details
- Industry sector
- 32
- Industry
- Pharmaceutical Preparation Manufacturing
- Occupation code
- 11-9121.00
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Listing ID: 8800d407-153e-4270-a67d-6198bfe999c3