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Regulatory Compliance Specialist
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Regulatory Compliance Professional
We are seeking a seasoned regulatory affairs expert to spearhead the development and implementation of strategic compliance initiatives.
The role involves preparing, reviewing, and submitting high-quality regulatory documentation to global health authorities, ensuring seamless compliance with applicable regulations.
Key Responsibilities:
- Developed and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Maintained comprehensive knowledge of international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Collaborated with regulatory authorities during product submissions, inspections, and audits.
- Designed and executed regulatory strategies to support new product development and lifecycle management.
- Conducted thorough reviews of labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintained up-to-date expertise on regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supported quality systems in alignment with ISO standards.
- Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
- Managed regulatory documentation archives and maintained compliance records for audits and inspections.
