
Principal Regulatory Affairs Professional
3 days ago
Job Title: Regulatory Affairs Specialist
Overview of Position:
We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team. The ideal candidate will have expertise in both pharmaceutical and medical device regulatory compliance.
The successful candidate will be responsible for preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.
Key Responsibilities include:
- Preparing and submitting regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interacting with regulatory authorities during product submissions, inspections, and audits.
- Developing and maintaining regulatory strategies to support new product development and lifecycle management.
- Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintaining up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supporting quality systems in alignment with ISO 13485 and FDA QSR standards.
- Collaborating with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assisting in responding to regulatory queries, deficiency letters, and inspection findings.
- Managing regulatory documentation archives and maintaining compliance records for audits and inspections.
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