Senior Regulatory Affairs Associate
Parexel(2 months ago)
About this role
Parexel is hiring a Senior Regulatory Associate focused on Chemistry, Manufacturing, and Controls (CMC) regulatory submissions for biotech and pharmaceutical products. The role supports global post-approval and lifecycle activities such as variations, renewals, and rollout submissions across multiple regions, interacting with clients and health authorities.
Required Skills
- CMC Submissions
- Regulatory Writing
- Variation Submissions
- Annual Reports
- MAA Rollouts
- Health Authority Responses
- GMP Submissions
- Site Registration
- Change Control
- CMC Packages
+5 more
Qualifications
- BS/BA/MS In Biological Or Health Sciences
- PhD
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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