Regulatory Affairs Cover Letter Samples

Bring drugs to market’, stakeholder management’ and ‘strategic input

are probably some of the phrases the internet bible, that is google, flagged up during your search of what a RA professional does. How does that translate into what the daily activities of a RA professional are, I hear you cry? Well sit back, relax and make yourself comfy for at least the next few minutes, as I will attempt to give you an idea of what you are signing up for when you submit your application before the 8th Feb.

Before I continue I have a little confession to make, whilst I am a RA graduate my first rotation is actually within Chemistry, Manufacturing and Control (CMC) Supply. One of the many beauties of the graduate program is the rotational element; one of your 8 month rotations will be outside of RA, but in a department closely aligned to RA, which leads me nicely into my next paragraph…

CMC Supply

CMC supply is a pretty awesome place to work because:

A) One day you may go into work to see an ice cream machine in the coffee room, which signals you to start salivating like one of Pavlov’s dogs

B) Following the arrival of said ice cream machine, your department manager may tell you to ‘help yourself to as much ice-cream as you want’ (adios waistline)

C) CMC Supply is the heart of the formulation and development of our drug products. In a nutshell, we are the middle men and women between our research laboratories discovering a novel drug product that can kick the ass of diabetes (and other other chronic disorders), and our colleagues in product supply, who manufacture the drug on a commercial scale to then ship to patients across the globe.

This was no mirage, there was an ice-cream machine in my office!

Now I should really get on with telling you a little about what I actually do:

’Bring drugs to market’

Think less breaking bad and more Phase 3 drug development, with the latter being a pivotal stage in the ‘bring drugs to market’ concept. In Phase 3 you compile and submit all your documents to health authorities as part of a new drug application (NDA). The NDA essentially proves that you have the coolest drug product out there, bar none. Recently, I authored one of the first documents from our department to be submitted to the FDA as part of the NDA. Thus highlighting that you get real responsibility from the get go and a real chance to apply yourself. However, it must be noted that such a task could not be completed alone and I was able to get by with a little help from my friends -not Paul McCartney and Co, but my stakeholders.

‘Stakeholder management’

Whether I am relying on a chemist in my department to review a protocol  I am writing, to ensure it is scientifically viable or a colleague in analytical support to give me input on validated methods used to test the stability of our drug product; stakeholders and their input is key to your day-to-day work. Don’t be surprised if you can sometimes spend the best part of a day in meetings with your stakeholders or find yourself negotiating deadlines for their input. I am quickly learning that if you manage your stakeholders well, you have won half of the battle in finalising a task you are responsible for.

‘Strategic input’

Recently I tried my hand at being strategic during the writing of a protocol for a study that confirms our drug product is degraded in light and hence must be stored away from light. Sounds simple right? Well not so simple, as we need to decide on what stability indicating test parameters we want to investigate. To cut a long story short, I made a suggestion of not including some test parameters in the submission package as part of that NDA application I told you about earlier, but still testing said parameters and keeping them in house in case FDA has questions around them. Apparently, this is a good suggestion and considering up until now, the most strategic thing I had done involved me placing hotels on the orange property set of the monopoly board and bankrupting my whole family in the process (sorry guys), I think it is safe to say I am learning and reaching new strategic heights.

It’s like looking in the mirror.

For me to be able to help in the process of bringing drugs to market, whilst managing various stakeholders and trying to give some strategic input from time to time I have been trained and continue to receive ample training to aid my development. Training will be the theme of my 4th blog post, so stay tuned folks :)


Tags: Career, Career path, Experiences, First rotation, Fun at Work, Graduate Program, Graduate programme, My Story, Regulatory Affairs

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My wife thinks that I have finally cracked. She believes that my affliction derives from too many years of opening envelopes or that I am feeling the strain of the many resumes I have read at night by the glow of the computer. Her concerns escalated just the other day, when she caught me reading my son bedtime stories that I had written for him about the job market. As I told her, I was just trying to teach him at an early age how to market himself into a good job. With all the competition out there, I want this boy ready when the time comes ...

Once upon a time, there were two interesting resumes which both wanted to attract the attention of Nancy Smith, assistant hiring manager at ABC Biotech. The first resume, a handsome six-pager in a gray envelope, said to the other, "I'm going to puff myself up real big and strong, and make it impossible for Nancy to miss me in that large stack." The second resume thought that this kind of behavior was inappropriate, but was too polite to say anything at first. But it thought for a minute, and then with a determined look said, "I'm going to cover myself with a short, powerful letter to Nancy so that she gets interested before she picks me up." The first resume laughed, and said in its most sarcastic tone, "What a silly little thing you are to think that a simple cover letter could make that kind of a difference. You're just a skinny, unattractive resume in a plain envelope. In fact, you won't even get a second look."

That morning, as the assistant hiring manager worked her way through the daily mail her eyes were drawn to the first resume, which stuck out from the pile in its gray pinstripe envelope. She opened the envelope and started to skim down the first page of the resume. "Gee, this resume has a lot of style and format, but not much content," she thought. The cover letter was of the mass-produced variety, simply restating the obvious education and credentials. After spending only a moment or two on it, Nancy set it aside with the others for filing. She continued opening the mail and skimmed a few other resumes in the same perfunctory manner. She stopped, however, when she came to that second resume, which included a letter personally addressed to her. "What an interesting package. This one hit the nail on the head. The cover letter describes our problem exactly, and then points out some accomplishments to look for in the resume. I'm going to read further on this one," she thought.

The little resume beamed, knowing that once an assistant hiring manager gets hooked, the story is almost certain to end "and they all lived happily ever after ..."

Seriously Now

Let's face it, cover letters are read and resumes are skimmed. In light of this, why is it that so many of us put such little effort into writing the cover letter? For most people, this is because they incorrectly believe that the cover letter is a throwaway, and that the resume or CV inside that envelope is what counts. Although it is entirely true that the resume has to be well written and have good content, the cover letter's job is to point to what lies inside, and to make it more specific to that reader. Just like the cover of a magazine.

Can you imagine how much fun it would be to browse the newsstand if every magazine on the shelf looked alike? Instead, the cover shows you what lies inside and summarizes some of the key things that you will find there.

Although we are allowed to put more into a cover letter than can appear on a magazine cover, the challenge is still to keep it succinct. In fact, writing something that is powerful and yet short is the single most difficult kind of business writing. You already know that although it's easy to go on and on in a company memorandum, saying the same thing in half the space can make your work twice as powerful. And that's what you'll have to focus on in the cover letter for your resume package. You'll have three or four paragraphs at the most, on one page, and you'll need to get the interest of the professional reader of these documents who spends an average of no more than 2 minutes on each resume.

Here are the three important areas to consider as you write a good cover letter:

Appearance. Some of the reminders that I have for you deal with the way that your package looks and the appearance of the letter. But your first concern should be to make certain that your multipage CV has enough postage on it. Twice a week we have to pay for postage that was shorted by people who believe that anything that fits into a #10 envelope will mail for 37¢. What a terrific impression these folks make when the company has to pay the postage due on their application!

The quality of your stationery, the presence or absence of typographical errors, and other details of your letter's physical appearance combine to reveal your taste and style. It is only when style becomes all-important, as in my fable above, that it can hurt you.

  • Don't forget that cover letters are often scanned along with the CV or resume. Make sure that you have used common fonts and that you have avoided italics and underlining.

  • Using personal stationery for the cover letter is a classy touch. Stationery is usually on high-quality cotton content paper, one size smaller than the 8.5" x 11" size of the resume. Generally, ivory or white paper looks the most professional.

  • Never try and save time by using a window envelope. Many a resume has ended up in the accounting department because of this blunder.

Format. A form letter introduction--one that attempts to make the same letter work for all recipients--is a shortcut to disaster. The impression such letters inevitably create, particularly those that are photocopied, is that the writer has embarked on a resume-mailing campaign to every biotech and pharmaceutical company in the Western Hemisphere. Instead, develop a personal letter to a hiring manager or personnel authority at the company. Research the company well enough so that you can fine-tune your comments in the cover letter to specific issues that they are facing. For example, if you are targeting a regulatory affairs position, and you see that the company has a major product going into the clinic soon, you'll know to describe your technical writing experience and your ability to assist them with this registration process.

  • A workable format: The first paragraph should introduce who you are and where you work; the second paragraph should refer to one of your most appropriate accomplishments; and the closing paragraph should suggest some sort of action or describe your availability to interview.

  • If you have trouble getting that middle paragraph about the accomplishment into a brief statement, try using a challenge-approach-results format. State the problem you were faced with (one or two sentences), the approach you used to solve it (one or two sentences), and finally what happened as a result (one or two sentences). Voila, you've got a paragraph!

Content. Henry Ford once said, "If there is any one secret of success, it lies in the ability to get inside the other person's point of view and to see things from his angle as well as your own." That's why, as stated above, you must specifically identify something in your background or in one of your achievements that best relates to the company's issues. Often the ad you are replying to is a give-away, and yet people neglect that important information. If the ad refers to cell culture experience, do not spend that important middle paragraph describing your experience with E. coli. That's why it's generally not a good idea to customize your letters by simply changing the name and address at the top.

  • Although it is OK to use some "boiler plate" copy, don't waste the opportunity to get your message fine-tuned to the job at hand.

  • Don't use words that are uncomfortable for you or that you wouldn't use in conversation. As an example, "My resume is enclosed for your perusal" should probably read, "My resume is enclosed for your consideration."

  • Avoid creating what professional writers call "I-strain." This refers to the constant use of the word "I," which can get very tedious in a cover letter, almost to the point of making you appear self-centered. After you write your letter, go through it to remove a few extra "I's". Instead of writing a closing comment like, "I can be reached after 7:00 p.m.," you could make it "You can reach me any evening after 7:00 p.m."

Will There Be More Sappy Fairy Tales?

No worries. My wife has convinced me that our son needs time to be a boy before he needs to start thinking about his approach to the job market. My career as the author of children's stories about the biotechnology job market officially comes to an end with this month's column.

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