Senior Regulatory Affairs Specialist
1 day ago
Job Opportunity:
We are seeking an accomplished Regulatory Affairs professional to join our team.
- Key Responsibilities:
- Compliance Management: Ensure regulatory compliance with international, federal, and local requirements across pharmaceuticals and medical devices.
- Documentation Submission: Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Regulatory Interactions: Engage with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
- Strategy Development: Develop and maintain regulatory strategies to support new product development and lifecycle management.
- Labeling and Promotions: Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Knowledge Maintenance: Stay up-to-date with regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Quality Systems: Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Cross-Functional Collaboration: Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Regulatory Queries: Assist in responding to regulatory queries, deficiency letters, and inspection findings.
- Document Archives: Manage regulatory documentation archives and maintain compliance records for audits and inspections.
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