CMC Regulatory Affairs Profesionals
Parexel(1 month ago)
About this role
Parexel is hiring a Senior Regulatory Associate focused on global Chemistry, Manufacturing and Controls (CMC) regulatory work in the biotech/pharmaceutical space. The role supports global post-approval regulatory maintenance and Health Authority interactions across multiple regions, contributing to therapies that improve patient health. It sits within a collaborative regulatory team environment with opportunities for growth and impact.
Required Skills
- CMC Submissions
- Regulatory Writing
- Variation Submissions
- Annual Reports
- Renewals
- MAA Rollouts
- Health Authority Responses
- Submission Planning
- eCTD Review
- Submission Publishing
+6 more
Qualifications
- BS/BA/MS In Biological Sciences
- PhD
- Degree In Regulatory Affairs
About Parexel
parexel.comFor over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.
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