
Regulatory Affairs Professional
5 days ago
Main Purpose of Role:
We are seeking a highly experienced and knowledgeable Regulatory Affairs Specialist to join our team. The ideal candidate will have comprehensive knowledge in the area of Regulatory Affairs and be able to execute complex projects.
- The Regulatory Affairs Specialist will direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- This individual will interact with regulatory agencies to expedite approval of pending registrations.
- They will serve as a regulatory liaison throughout the product lifecycle.
Key Responsibilities:
- Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
- Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
- Serve as a regulatory representative to marketing, research teams, and regulatory agencies.
Qualifications:
- Education: Bachelor's degree in a relevant field.
- Experience: Minimum 7 years of experience in Regulatory Affairs.
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