Regulatory Affair Specialist

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Regulatory Affair Specialist

Regulatory Affairs Specialists in health sciences are essential stewards of patient safety and product quality. Their role revolves around navigating the complex landscape of healthcare regulations, ensuring that pharmaceuticals, medical devices, and healthcare products meet stringent quality and compliance standards.

These professionals collaborate with cross-functional teams, including scientists, engineers, and legal experts, to facilitate the development, approval, and post-market compliance of healthcare products. They prepare and submit regulatory submissions, such as applications for clinical trials and marketing approvals, and serve as intermediaries between their organizations and regulatory authorities.

 

 

 

 

 

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Responsibilities

  • Prepare and submit regulatory documents.
  • Ensure compliance with industry regulations.
  • Stay updated on regulatory changes.
  • Liaise with regulatory agencies.
  • Review product labeling and marketing materials.
  • Provide regulatory guidance to project teams.
  • Coordinate responses to regulatory agencies.
  • Maintain regulatory submissions and approvals database.
  • Support post-market surveillance activities.
  • Participate in internal and external audits.
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Education

Educational qualifications for Regulatory Affairs Specialists typically include a bachelor's or master's degree in regulatory affairs, life sciences, pharmacy, or a related field. Specialized training and certifications, such as Regulatory Affairs Certification (RAC), can significantly enhance qualifications.

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20+ Years Experience

20+ Years Experience

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Robust Talent Network

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Efficient Recruiting

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Focus On Compliance

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