
Senior Regulatory Affairs Specialist
5 days ago
Our Regulatory Affairs Executive will lead the compilation of marketing authorization applications for EU, UK and AUS-NZ in eCTD format. They will submit these to respective regulatory agencies. Additionally, they will compile and submit variation applications for the same regions.
">Responsibilities:- Compile modules 1, 2, and 3 of Initial Marketing Authorization Applications
- Submission to respective Regulatory Agencies
- Compilation and submission of variation applications
- Review of documents related to dossier compilation and query responses
Key Qualifications:
- Hands-on experience with eCTD software and e-publishing requirements
- Initial MAA submission and Variations for EU experience
- Strong knowledge of CTD/eCTD requirements for modules 2 and 3
- Compilation of module 1 and portal submissions (desirable)
We are looking for an individual with excellent analytical and learning skills. Strong communication and interpersonal skills are essential.
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