Pharmaceutical Education, University Education , other training, experience in the pharmaceutical industry and relevant skills are the main determinants of a successful career in regulatory affairs. Careful plan is required in acquiring the right blend of these elements . It’s possible to waste a lot of time not doing things that add value to competence resulting in missed opportunities.
I have created a hypothetical model in which a persons Pharmaceutical education along with a bachelors degree in life sciences contributes 20% of what I have called the “acceptance grade”. Most jobs in Regulatory Affairs require a Bachelors degree in life sciences and a certificate/Diploma showing pharmaceutical training. You will most likely not be invited for interview if you don’t have a Bachelors degree.
I have allocated a maximum of 40% of the “acceptance grade” to experience for an advertised post that requires 5 years experience. The highest “acceptance grade” is awarded to a candidate with 5 years experience. A candidate with 1 year experience gets only 8%. See table below to see how years of experience influence the final acceptance grade.
Relevant skills,knowledge,personal attributes such attitude and reliability that help the applicant to do the job well contribute 40% to the acceptance grade. In this example we have 15 essential job requirements. The list may vary from one job to another. My purpose is to illustrate that the requirements in job postings should be treated seriously. If you claim to have a skill you don’t have, the interviewing panel will find out and you may be classified as unreliable and dishonest. Be truthful and they will respect you for it.
Some people attend and fail many interviews because they lack an eye for detail, lack follow up skills, can’t work independently, aren’t good team players, appear to be unreliable and lack problem solving abilities. Unfortunately these skills and personal attributes cannot be acquired easily through pharmaceutical education alone. They may take a longer time to develop than taking a course. Some of them depend on your character and personality such as being a “team player”. You have to identify your own short comings. Be honest with yourself and plan to change or look for a job that matches your skills.
What about reading, writing and speaking skills? If your native language is not English , these English skills may take longer to acquire than others. They can however be acquired if you have a plan. We may be able to help if you contact us.
Column A below shows an example of the ideal candidate with all the listed qualifications and job requirements plus 5 years experience in regulatory affairs as advertised. In real life it’s hard to come across many such a candidates. You may qualify for interview even though you lack one or 2 job advertised requirements provided you excel in other areas.
When having advertised job requirements and experience trumps over certificates and diplomas
Columns D, E & N in the table below shows candidates with all the listed skills and 3,4 or 5 years of experience but don’t have a diploma or a certificate showing pharmaceutical education.
These candidates score 77%, 85% and 93% respectively and have a high chance of being employed. In addition to other skills, these candidates have transferable skills and attributes such as good communication skills, problem solving skills, follow up skills , reliable, team players, work independently and have an eye for detail.
As you can see having all the advertised job requirements and experience trumps over a certificate or diploma. A certificate/diploma is important but may not be adequate. For best results make sure that the certificate or diploma helps you to acquire most of the skills required in your area of interest.
We recommend that you acquire as many relevant skills as you can in your current job or training. This will help you a long the way when new opportunities arise.
Pharmaceutical education and experience
Columns B and C in the table below shows the effect of experience for a person who lacks Pharmaceutical Training. Two or more years of experience has a significant effect on the acceptance grade. A person without evidence of Pharmaceutical Education but with two years experience in the pharmaceutical industry is more preferred than a person with no experience or with 1 year experience.
Column M in the table below shows that a person with no experience, no certificate or diploma has 53% of the acceptability criteria . Such a person may be invited for an interview if that person has a significant number of the essential job requirements.
Acquired skills trump over irrelevant experience
Columns A,B, F,G,H,I and J in the table below show how increasing the number of years of experience can bias the acceptability criteria despite the lack of essential skills. While a candidate may be invited for an interview they are unlikely to be hired because they lack the essential skills.
Lack of pharmaceutical Education and Experience
It’s possible to be hired without Pharmaceutical education training certificate/ diploma or much experience but you are unlikely to be hired if you don’t have the key job requirements. Column L in the table below shows that a person without Pharmaceutical Education certificate diploma or experience but with only 7 of the 15 job requirements has only 35% of the “acceptance grade”. Such a person is unlikely to be invited for interview. Column N in the table below shows that a person without Pharmaceutical Education or experience but with all the 15 job requirements has 53% of the acceptance grade. This person has better chance of being invited for interview than the person in column L.
Sample eCTD Job application checklist and possible evaluation outcomes | |||||||||||||||
A | B | C | D | E | F | G | H | I | J | K | L | M | N | ||
EDUCATION | |||||||||||||||
Computed Contribution of education to evaluation grade % | 20 | 13 | 13 | 13 | 13 | 20 | 20 | 20 | 20 | 20 | 20 | 13 | 13 | 13 | |
Minimum of Bachelors degree in life Sciences | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
Pharmaceutical Training certificate/Diploma | 50 | 0 | 0 | 0 | 50 | 50 | 50 | 50 | 50 | 50 | 0 | 0 | 0 | ||
Total for this category | 150 | 100 | 100 | 100 | 100 | 150 | 150 | 150 | 150 | 150 | 150 | 100 | 100 | 100 | |
Experience in regulatory Affairs | |||||||||||||||
0 Years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
1 Year | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
2 Years | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | |
3Years | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | |
4Years | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | 80 | |
5 Years | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
Computed Contribution of “experience” to evaluation grade( %) | 40 | 8 | 16 | 24 | 32 | 8 | 16 | 24 | 32 | 40 | 0 | 0 | 0 | 40 | |
RELEVANT SKILLS & ATTRIBUTES | |||||||||||||||
Computed Contribution of skills & attributes to evaluation grade (%) | 40 | 40 | 40 | 40 | 40 | 40 | 32 | 26.7 | 21.3 | 13.3 | 40 | 21.3 | 40 | 40 | |
Knows eCTD guidelines | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 0 | 0 | 10 | 0 | 10 | 10 | |
Advanced skills in MS Word | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 0 | 0 | 10 | 0 | 10 | 10 | |
Ability to use Adobe Acrobat | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 0 | 0 | 10 | 0 | 10 | 10 | |
Document merging and splitting | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 0 | 10 | 0 | 10 | 10 | |
Create Bookmarks and hyperlinks | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 0 | 10 | 0 | 10 | 10 | |
Knows publishing and validation software | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 10 | 0 | 10 | 10 | |
Problem solving skills | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 0 | 10 | 10 | 10 | 10 | |
Reliable | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 10 | 10 | 10 | 10 | |
Team player | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 10 | 10 | 10 | 10 | |
Works independently | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 10 | 10 | 10 | 10 | |
Excellent reading, writing & speaking skills | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
Has follow up skills | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
Knows Health Canada regulations | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
Knows pharmaceutical industry | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 0 | 10 | 10 | |
Has an eye for detail | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
Total for this category | 150 | 150 | 150 | 150 | 150 | 150 | 120 | 100 | 80 | 50 | 150 | 80 | 150 | 150 | |
Maximum for this category | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | |
Evaluation grade final score | 100 | 61 | 69 | 77 | 85 | 68 | 68 | 71 | 73 | 73 | 60 | 35 | 53 | 93 | |
Conclusion
If you would like to work in Regulatory Affairs and and play a significant role in submitting eCTDs to Health Canada or the FDA, consider taking an appropriate course in Regulatory Affairs. As mentioned above pharmaceutical education is essential for success in the pharmaceutical industry.
Learn the key skills that are common in jobs advertised. Improve on your personal attributes as described above.
If you don’t find a job immediately after the course, volunteer where you are likely to learn either transferable skills or job specific skills. As you volunteer prepare and give your undivided loyalty to the organization as if you are employed there. You will be remembered when you leave. You will also get a good reference. Work hard even if you are not being paid.
The lessons you learn while you volunteer will contribute towards your “employability” .
We offer some online courses in Regulatory affairs. We also provide limited internship opportunities to those who graduate from our courses.