
Pharmaceutical Regulatory Affairs Professional
6 days ago
Regulatory Compliance Expert
We are seeking a seasoned Regulatory Compliance professional with expertise in pharmaceutical and medical device regulatory affairs.
Key Responsibilities:- Developed, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensured adherence to international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Maintained positive relationships with regulatory authorities during product submissions, inspections, and audits.
- Established 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 standards.
- Collaborated with cross-functional teams to integrate regulatory requirements into product development.
The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.
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