Regulatory Affairs Managers
Special Requirements
Regulatory Affairs Certification, known as the RAC, is the only certification specifically for regulatory professionals in the healthcare product sector. The RAC credential is a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession.
Four different certifications are available:
· RAC (US): knowledge of US regulations
· RAC (EU): knowledge of European Union regulations
· RAC (CAN): knowledge of Canadian regulations
· RAC General Scope (GS): knowledge and critical thinking skills related to the general scope of practice of regulatory professionals throughout the product
How to Get RAC-Certified
Candidates for the RAC take one of the four certification examinations (US, EU, CAN, or GS). The exams are computer-based and administered at multiple locations throughout the world during semi-annual, two-month testing periods: April/May and October/November. The regional exams address laws, regulations, policies and guidelines affecting regulated healthcare products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The GS exam tests knowledge of regulatory practice and international standards as well as critical thinking skills.
Candidates for the RAC take one of the four certification examinations (US, EU, CAN, or GS). The exams are computer-based and administered at multiple locations throughout the world during semi-annual, two-month testing periods: April/May and October/November. The regional exams address laws, regulations, policies and guidelines affecting regulated healthcare products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The GS exam tests knowledge of regulatory practice and international standards as well as critical thinking skills.
Eligibility Requirements
To be eligible for the RAC Examination you must demonstrate one of two basic requirements:
• Bachelor’s (Baccalaureate) degree or its equivalent or
• at least three years of regulatory experience
Applications from individuals who do not meet these basic requirements will not be accepted.
Applying For The Exam
The RAC exam application is available online. Candidates may apply online, and submit registrations fees by credit card, or may print a copy of the application form for submission by fax or mailing. It is the responsibility of the candidate to contact RAPS to confirm receipt of applications submitted via fax or mail.
No applications will be accepted after the final deadline.
The RAC exam application must be fully completed by the applicant. Applicants must acknowledge that they meet the application and have read the Code of Ethics for Regulatory Professionals. Applications must be received by the deadlines listed above. . All deadlines are postmark dates. For purposes of clarity, the term “postmark date” includes system date/time stamps for online, email and fax applicants.
Applications will not be accepted after 11:59 pm (US Eastern Time) on the late deadline date. Applicants will receive email or written notification that their application has been accepted/not accepted within 10 business days of receipt of application by the RAC Program office. Questions regarding application receipt should be directed to the RAC Program office.
Required Fees:
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First Time Application
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Re-examination
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Initial Deadline
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Late Deadline
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Initial Deadline
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Late Deadline
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RAPS member
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$325.00
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$375.00
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$225.00
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$275.00
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Non-member •
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$510.00
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$560.00
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$410.00
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$460.00
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• Fee includes one year of RAPS membership. Membership may be waived, however the fee remains the same.)
The data sources for the information displayed here include: Virginia Career VIEW Research. (Using onet28)
