Regulatory Affairs Consultant – CMC, Biological, Vaccines
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Job Description
Regulatory Affairs Consultant handling CMC submissions for biopharmaceutical company. Author global CMC documents and ensure compliance with regulatory requirements across regions.
Responsibilities:
- 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:
- N/A
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