
Expert Regulatory Affairs Professional
2 days ago
Job Title: Regulatory Affairs Expert
We are seeking a seasoned professional to spearhead our regulatory affairs operations, ensuring seamless compliance with pharmaceutical and medical device regulations.
The ideal candidate will be responsible for crafting, reviewing, and submitting high-quality regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
Key Responsibilities:
- Crafting regulatory strategies to support new product development and lifecycle management.
- Maintaining up-to-date knowledge of international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interacting with regulatory authorities during product submissions, inspections, and audits.
- Reviewing labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Managing regulatory documentation archives and maintaining compliance records for audits and inspections.
Requirements:
- Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
- Experience with regulatory authorities, such as FDA, EMA, CDSCO, MHRA, and Notified Bodies.
- Knowledge of international, federal, and local regulatory requirements.
- Familiarity with quality systems, such as ISO 13485, ICH, and FDA QSR standards.
About Us:
We are dedicated to providing high-quality services in the field of regulatory affairs. Our commitment is to ensuring compliance with applicable regulations and staying up-to-date on the latest industry best practices.
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