
Global Regulatory Compliance Manager
1 day ago
Key Responsibilities:
- Prepare, review, and submit regulatory filings for global health authorities.
- Ensure compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
- Interact with regulatory authorities during product submissions, inspections, and audits.
- Develop and maintain regulatory strategies for 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.
- Manage regulatory documentation archives and maintain compliance records for audits and inspections.
Requirements:
- Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
- Knowledge of international, federal, and local regulations across pharmaceuticals and medical devices.
- Ability to interact with regulatory authorities and manage regulatory documentation.
- Excellent communication and problem-solving skills.
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