Being recognized as a RAPS Fellow: How to maximize the application process
By RAPS Fellows CommitteeThe Regulatory Affairs Professionals Society (RAPS) Fellows program recognizes regulatory professionals who have made significant contributions to the profession. The Fellows program was established in 2008 and to date 141 professionals have been recognized as RAPS Fellows.
To qualify as a RAPS Fellow, candidates must meet the following criteria:
- Active RAPS membership (except those currently employed at a health agency)
- A minimum of least 10 years of extensive regulatory experience in healthcare products such as medical devices, pharmaceuticals, biologics, etc.
- History of dedication and ongoing commitment to advancing the regulatory profession
- Regulatory management and leadership experience
- Knowledge and understanding of critical regulatory issues
- Esteemed professional regulatory employment history
- Support of continuing education and professional activities
In addition, RAPS Fellows are expected to:
- Provide leadership and ongoing representation at RAPS programs and scientific meetings
- Participate in forums on key regulatory issues and trends
- Assist in developing future RAPS leaders
- Mentor new and/or junior RAPS members and other regulatory professionals by providing guidance and advice
- Continue contributing knowledge, experience and expertise to the profession
In 2023, almost 40% of applicants received recognition. To help facilitate an understanding of the application and review process, the following information provides some insight into common review challenges.
How Applications Are Assessed
Want to know how your application is evaluated? Your application once completed is routed to the RAPS Fellows Committee. Applications are peer reviewed by multiple Fellows. To make the process objective, if a Fellows Committee member knows you, they must recuse themselves from review of your application. Table 1 provides a review of the application review categories.
Table 1: Overview of the RAPS Fellows Categories| Evaluation Criteria |
| A. Contributions to the regulatory community. |
| 1. Volunteer positions held in service to RAPS |
| 2. Volunteer positions held in service to the regulatory profession through other external organizations |
| 3. Mentoring of new and/or junior professionals or others in the regulatory field |
| 4. Education and training activities, including professional presentations, poster abstracts/presentations, development and leadership of workshops and/or symposia related to the regulatory profession, and/or university courses and seminars |
| 5. Publications related to the regulatory profession |
| B. Work History |
| • Credit for every year of regulatory experience |
| • Additional credit given for significant contribution throughout the work history |
| • Note: looking for a minimum 10 years in regulatory |
| C. Management and leadership experience |
| • Minimum 10 years |
| D. Knowledge and breadth of regulatory issues |
| Credit for each level of the Regulatory Competency Framework (be flexible if the person does not touch all areas) |
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Level 1: Professionals at this level acquire knowledge related to the regulation of healthcare products, including regulatory frameworks, requirements, legislation and processes. Key Skills: Basic project management, communications, interpersonal skills and the ability to understand scientific and health concepts. |
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Level 2: Professionals at this level have a strong foundation in the regulatory profession, including scientific, legal, policy and regulatory process management. Key Skills: Well-developed regulatory technical knowledge and skills. Regulatory Affairs Certification (RAC) is targeted to professionals at this level. |
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Level 3: Professionals at this level understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. Key Skills: Integrates technical knowledge with management and strategy. Models desirable competencies to colleagues. |
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Level 4: Professionals at this level take on the role of the strategic regulatory lead while developing new approaches for achieving or defining business objectives. Strategic planning and working with other teams throughout the product lifecycle—both within and outside the individual’s organization—are among the most important responsibilities. Key Skills: Navigates ambiguity and demonstrates agility and other executive characteristics. Possesses and communicates strong understanding of the requirements, opportunities, risks and alternatives for developing and maintaining products. Sets the tone for ethical standards of behavior. |
| E. Plans for Advancing the Regulatory Profession |
| Assess the quality of the intentions based on inspiration and aspiration |
| F1. RAPS membership |
| • Credits for years of RAPS membership from 1 to 13+ years |
| F2. Membership in other organizations |
| Credits for membership in related profesional organizations< |
| F3. Additional professional designations or qualifications |
| • Professional degree/honor (MS, DBA, JD, non-RAPS Fellow, etc.) |
| • Professional certificate or non-RAPS certification |
| • RAC |
RAPS encourages everyone who qualifies to apply. Please treat the application as you would any large submission, budget enough time to compile the information for the application, complete the application and review it prior to final submission.
Issues with Applications
To help increase the rate of qualified professionals being recognized as Fellows, below are some of the consistent application issues seen over the past 5 years. These issues prohibit maximizing the credit given to an individual applicant:
- Incomplete application, lack of attention to detail, not filling in the requested information, missed information, grammar issues, formatting or even incomplete sections
- Did not contribute to the profession outside of normal job responsibilities.
- Did not provide a plan for how they would or could contribute to the profession going forward.
- Do not provide links to LinkedIn or other social media accounts; they will not be reviewed
The Fellows Committee Reviewers are limited to assessing only information provided in the application. More details on specific application issues that make it difficult for the RAPS Fellow’s Committee to give full credit and ultimately recognition as a Fellow is summarized in Table 2.
| Application Issue | Result | Resolution |
| Applicant says “see resume” for employment information | Reviewers of the application don’t have full employment history to properly assign credit that count towards Fellow’s designation. | The application asks for a full employment history to be entered into the application; please enter all relevant employment information into the application. |
| Incomplete application | Without all the information filled in, reviewers cannot evaluate all the contributions that a candidate made. | Take the time to fill out the entire application and give yourself all the credit for the contributions to the profession, don’t assume the reviewers know who you are and all you have contributed. |
| Lack of work experience in regulatory | Credit is given for duration of regulatory experience only. | Do not apply until the regulatory experience requirement has been reached. If the job title is not explicitly regulatory, please provide detail to explain how your job includes regulatory responsibilities. |
| Deficit in volunteer activities | Little to no credit assigned for this category | Get more involved with regulatory activities outside of work; volunteer time to educate peers. Signing up to volunteer for committees and meetings 2 months prior to the application does not count towards this qualification. This category needs to demonstrate a commitment towards volunteering towards advancing the profession over time. |
| Lack of leadership or management experience | No credit is provided for this section | This could be due to not explaining your contributions to the profession. |
| Mentoring: lists everyone they’ve ever worked with | Mentoring is expected to go beyond the typical supervisory/management activities. | Mentoring needs to be an ongoing relationship you’ve had with a person to help them learn and grow. You spend time every week or month with them to help them navigate situations and develop their critical thinking skills. If someone works for you, you are obligated to mentor them; this is really for those you’ve mentored above and beyond work commitments. |
| Declaring trainings attended as professional presentations performed | No credit for training experience or volunteer work | You must be a presenter or panel member to claim credit for a training. |
| No specific plan for how to contribute to the profession after designation | No credit given for this portion of the application | Complete a detailed plan for how you plan to contribute to the profession going forward. |
| Does not hold RAC | No credit | This is the easiest credit on the application; take the RAC today! |
| Not a RAPS member | Application rejected if not a RAPS member. | Become a RAPS member. |
Ready to become a RAPS Fellow? You can submit your application here.