Pharmaceutical Regulatory Affairs Specialist
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Pharmaceutical regulatory affairs specialists manage the regulatory aspects of bringing new pharmaceutical treatments to market, ensuring compliance with regulatory standards.
Key Responsibilities
- Preparing and submitting regulatory documents.
- Ensuring compliance with regulatory requirements.
- Liaising with regulatory agencies.
- Monitoring and interpreting regulatory changes.
- Supporting clinical trials and product development.
Required Qualifications
- Bachelor's degree in life sciences, pharmacy, or a related field (minimum).
- Certification in regulatory affairs (e.g., Regulatory Affairs Certification, RAC) (optional but preferred).
Career Pathways
- Regulatory Affairs Specialist
- Director of Regulatory Affairs
- Regulatory Affairs Consultant
Related Organizations and Employers
- Regulatory Affairs Professionals Society: RAPS
- The Organization for Professionals in Regulatory Affairs: TOPRA
- The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use: ICH
- Food and Drug Administration (FDA): FDA Careers
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