
Expert Pharmaceutical Compliance Specialist
2 weeks ago
Job Title: Regulatory Affairs Professional
Location: Remote
Position Overview:
We are seeking an experienced regulatory affairs expert with expertise in pharmaceutical and medical device compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities.
Key Responsibilities:
- Developed and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Maintained compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
- Collaborated with regulatory authorities (FDA, EMA, CDSCO, MHRA) during product submissions, inspections, and audits.
- Developed and implemented 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.
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