Senior Regulatory Affairs Associate (CMC)
Parexel(2 months ago)
About this role
Parexel is seeking a Senior Associate in Regulatory CMC to support the development and lifecycle management of pharmaceutical products, with emphasis on biologics (vaccines preferred) across EU and US FDA regions. The role focuses on shaping CMC regulatory strategy and guiding submissions for both early-stage programs and marketed products while partnering with cross-functional stakeholders to support successful product development and commercialization.
Required Skills
- CMC Strategy
- Regulatory Submissions
- IND
- IMPD
- Post-Approval Variations
- Annual Reports
- Health Authority Responses
- Change Control
- Manufacturing Changes
- Regulatory Assessments
+9 more
Qualifications
- PhD in Pharmaceutical Sciences
- Advanced Degree in Chemistry
- Advanced Degree in Chemical Engineering
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.
View more jobs at Parexel →Apply instantly with AI
Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.
More jobs at Parexel
Similar Jobs
Senior Director, Regulatory Affairs CMC
Alcon(12 days ago)
Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals(5 days ago)
Senior Director, CMC Regulatory Affairs
Praxis Precision Medicines, Inc. (1 month ago)
Executive Director, Regulatory CMC
BridgeBio Pharma(7 days ago)
Associate Director, Regulatory Affairs, CMC
BeOne Medicines(9 days ago)
Director, CMC Regulatory Affairs
Capricor Therapeutics(17 days ago)