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The Regulatory Affairs Certification Board (RACB) is the governing body responsible for administering the RAC certification exam program and ensuring its fairness, relevance, and quality. The RAC credential is open to regulatory professionals worldwide and can be earned through documented education and work experience, passing a comprehensive exam, and abiding by the Code of Ethics. RAC Board Members are appointed for a three-year term, with a maximum of two consecutive terms, and a total of nine consecutive years of service on the RACB or any exam committee.The RACB has the following responsibilities:• Develop, implement, and administer the RAC program • Establish and maintain policies and procedures for the program • Ensure the fairness and quality of the program• Approve changes to the RAC qualifications and exam structures • Appoint and oversee exam committees• Ensure reliability and validity of exams • Approve recertification conditions and credits • Review and approve recommendations for vendors and consultants • Recommend establishing new exams or elimination of exams no longer viable • Assist the RAPS Affiliate Board in governing the RAC program The RACB holds one in-person meeting each year, in conjunction with the RAPS Annual Conference. The RACB also meets occasionally, as needed, via teleconference or through other electronic communications. Any special initiatives which you may be asked to undertake on behalf of the RACB will be based on your approval and your availability. To be eligible to serve on the RACB, regulatory professionals must meet the following requirements:Required• Minimum of 10 years of experience in the regulatory profession • Director level experience or above• At least 5 years of expertise in drugs, devices, and/or combination products • Able to consider all viewpoints and perspectives • Able to attend an average of 2 hour-long meetings and 1 full day meeting per year (three-year term commitment) • Able to maintain the confidentiality of sensitive exam information Desired • RAPS membership • RAC credential holder• EU representation• Experience with RAC item writing or RAC committee experience
Leeann Manlove
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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