OK, so it’s a beautiful day, you came early to the office and you are so ready to spread that Regulatory Affairs love. There are a couple of proven ways to show your expertise, helpfulness and appreciation to your colleagues that will turn you into their favourite colleague in no time:
1. Your colleague Mark not answering your emails?
Come in early to the office. Carefully monitor entrance to the Mark’s office. As soon as you see him, run towards him and start discussing your problem. Mark will be delighted.
2. You are given a regulatory task you don’t have a clue how to do?
Setup a meeting with all product team members. Explain there is an issue and collect the team’s opinions. Write everything down and present to your boss.
3. Having a new non-substantial clinical trial protocol amendment?
Insist on informing all authorities/Ethics Committees to be on a safe side. Repeat your position in a meeting and in writing afterwards (again to be on a safe side).
4. One hyperlink error noticed in the Quality Overall Summary just before the dossier submission?
Better halt and delay the submission until the error is corrected. You don’t want to be the one who destroyed the whole submission after all. Better safe than sorry.
5. Jen, your pharmacokinetic (PK) team member, informs that after a repeated analysis the PK results seem OK
Better go to her manager and ask the same question. Document in writing and cc your boss.
6. European Medicines Agency asked a question related to your dossier?
Insist on submitting everything you have, to avoid getting further questions.
7. Your clinical colleagues not sure how to address a particular clinical topic and ask for your take on this topic?
Send them an email containing a link to the guideline. They can read, can’t they?
8. You promised to check on something and forgot?
Keep shut and act as it never happened. If they remind you insist that this was not your task.
9. Medical team having comments to the already authority approved SmPC sections with no new data to support the change?
Use passive-aggressive tone to “point out” that the text cannot be changed and that everyone should already know this by now. Throw in a snarky remark or two and send a corresponding SOP to the offenders.
10. Received 100 comments to the draft SmPC?
Ignore “less important” ones with no explanation. When conferred explain that only important comments have been addressed.
11. Asked to interpret the guideline for the particular situation?
Send an email with quoted sentences from the guideline. Don’t forget to mention that it is company’s obligation to follow the guideline.
12. Need to review the IND documents?
Focus on the most important things: typos, lower/upper cases, spaces, “ml” vs “mL”, numbering, bulleting and other similar crucial errors. Scroll through the science part.
13. Your clinical project manager needs clinical trial submission and approval timelines?
Since nobody can predict the timelines, send the most pessimistic scenario and cite the regulation.
Do you have any examples of ways to be “loved” by your colleagues?
And remember, this article contains sarcasm and it is for fun only…