Regulatory Affairs Expert with ANDA Experience
11 hours ago
About Lifelancer and the Role
Lifelancer is a talent-hiring platform connecting professionals in Life Sciences, Pharma, and IT with opportunities. As a Regulatory Affairs Officer, you will play a crucial role in ensuring compliance with regulatory requirements for pharmaceutical products.
Salary: $80,000 - $110,000 per year
We are seeking an experienced Regulatory Affairs Officer to join our team. The ideal candidate will have hands-on experience with eCTD software, including SPL generation, registration of new drug products, sequence creation, and uploading of modules for eCTD submission.
Key Responsibilities:
- Facilitate annual report preparation for solid oral products
- Demonstrate stability data review, BPR review, validation report reviews, and human prescription drug labeling
- Prepare labelling section 1.14 in module 1 of the ANDA dossier
- Support the preparation of several sections of Module 32s 32p
Benefits:
- Competitive salary range
- Opportunity to work with a talent-hiring platform in Life Sciences
- Chance to develop skills in eCTD software and regulatory affairs
Lifelancer's Platform
Lifelancer connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Our platform offers a unique chance to grow professionally and expand your network.
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