
Medicinal Product Compliance Expert
2 days ago
Regulatory Compliance Professional
We are seeking an experienced professional to join our team as a Regulatory Compliance Specialist.
About the Role:
The successful candidate will be responsible for ensuring compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices. This includes preparing, reviewing, and submitting regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Key Responsibilities:
- Prepare and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interact with regulatory authorities during product submissions, inspections, and audits.
- Develop and maintain regulatory strategies to support new product development and lifecycle management.
- Review labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices.
- Support quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Collaborate with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
- Assist in responding to regulatory queries, deficiency letters, and inspection findings.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.
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