Leading Regulatory Affairs Specialist
7 days ago
About the Role:
We are seeking an experienced Regulatory Affairs professional with a strong background in ANDA submissions and US FDA compliance.
- Manage the end-to-end preparation and submission of Abbreviated New Drug Applications (ANDAs) and related post-approval submissions including Annual Reports, Complete Response Letters (CRLs), and Information Requests (IRs).
- Coordinate with cross-functional teams to collect required data and documentation for timely regulatory submissions.
- Review and compile CMC documentation in compliance with FDA guidelines; ensure manufacturing and control processes meet regulatory expectations.
- Lead and mentor junior regulatory team members, ensuring best practices and knowledge transfer.
- Identify regulatory risks early and implement mitigation strategies across multiple product portfolios.
- Collaborate with internal stakeholders to maintain regulatory compliance throughout product lifecycle, including change control management.
Requirements & Skills:
- Masters degree in Pharmacy, Chemistry, Life Sciences or related field.
- 8+ years of hands-on experience in US FDA regulatory submissions, especially ANDA dossier compilation and lifecycle management.
- Strong understanding of eCTD structure, FDA portals, SPL submissions and labeling requirements.
- Proven experience in change control assessment, regulatory impact analysis and risk-based submission planning.
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