
Regulatory Compliance Expert
3 days ago
Key Responsibilities of Regulatory Affairs Specialist:
- Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensured compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
- Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
- Developed and maintained regulatory strategies to support new product development and lifecycle management.
- Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
We are seeking an experienced professional with expertise in both pharmaceutical and medical device regulatory compliance.
- Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
- Ability to maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices.
The ideal candidate will have a strong track record of success in regulatory affairs and be able to demonstrate their expertise in supporting product development, registration, and commercialization.
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