Regulatory Affairs Professional
1 week ago
About Us
Lifelancer is a talent-hiring platform connecting professionals with opportunities in the life sciences, pharmaceuticals, and IT sectors.
Estimated Salary: $80,000 - $110,000 per year based on industry standards and location.
Job Description:
- Assisted in preparing annual reports for solid oral products.
- Reviewed stability data, BPR documents, validation reports, and human prescription drug labeling.
- Promoted labelling section 1.14 in module 1 of ANDA dossiers.
- Contributed to the preparation of various sections within module 32s and 32p.
- Fostered hands-on experience with eCTD software (PharmaReddy) for SPL generation, new drug product registration, sequence creation, and uploading modules for eCTD submission.
- Coordinated submissions via ESG.
Required Skills and Qualifications:
- Experience with Regulatory AffairsBpharmAbbreviated New Drug Application (ANDA).
- Strong knowledge of Patent and Exclusivity, Prior Approval Supplement (PAS), Changes to ANDA, and ICH Q6-A regulations.
- Excellent communication and project management skills.
Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
How to Apply: Please visit Lifelancer's job portal to apply for this position.
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