Regulatory Affairs Consultant – CMC, Biological, Vaccines
Parexel
full-time
Posted on:
Location Type: Remote
Location: Mexico
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About the role
- Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs
- Prepare and review CMC packages
- Support GMP submissions
- Manage change control assessments
- Ensure compliance with regulatory requirements across multiple regions
- Act as the main GRA point of contact for LRAs and other stakeholders
- Author Administrative and CMC regulatory documents/deliverables
- Collaborate with project SMEs and client stakeholders to prepare submission packages
Requirements
- University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
- At least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry
- Strong technical regulatory expertise
- Excellent writing skills
- Ability to evaluate scientific CMC information for accuracy
- Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products (MANDATORY)
- Strong regulatory CMC writing skills
- Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
Benefits
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Applicant Tracking System Keywords
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Hard Skills & Tools
CMC regulatory affairsGMP submissionsregulatory document authoringchange control assessmentsscientific CMC information evaluationbiological sciencesvaccinessmall molecule medicinal productsregulatory compliancetechnical regulatory expertise
Soft Skills
excellent writing skillscollaborationstakeholder communicationattention to detailorganizational skills
Certifications
university degree in biological sciencesPhD in related health sciences