Regulatory Affairs specialist, Marcella Marzona, reveals her tips for success when writing your CV.

5 March 2017

This article originally appeared on LinkedIn.

I have read many CVs during my seven years working in extremely competitive and saturated international recruitment markets. And I want to share the feedback from the many calls I’ve had with clients over the years.

It is vital that you give yourself the best chance to make an amazing first impression and demonstrate that you are the most suitable person for the role. Here are some points to remember:

  • Especially if you’re looking to land your job abroad, it is important to choose the classic Word document format because it is simple and easily readable. Stick to a single column document with paragraphs, tabs, bullet points and bold / italic fonts. 

  • No grids, infographics, or coloured shapes in the background please - these can wreak havoc with overlapped text and transposed grids. Keep the visuals simple.

  • The CV is a summary of the key elements of your specialism. This is what will grab the hiring manager's attention and his or her curiosity to know more and ultimately invite you to an interview.

  • I have never come across a ‘2 pages maximum’ requirement from hiring managers. Quite the contrary, they want to know everything about you, so include all your relevant experience (if it goes to six pages, so be it!)

CV template example

As you’ll see in the example below, you can easily incorporate all the important information for each separate part of your work experience into a few paragraphs.

Your profile
Start with a brief introduction about yourself. This should be a short paragraph of 4-6 lines where you include the key elements of your background and experience.

E.g. Regulatory Affairs expert with 10+ years’ experience covering several roles such as Project Manager and Associate Director. Knowledge of CTA / IND, MAA / NDA and LCM of Small and Large Molecules products in therapeutic areas such as Oncology, CNS, Respiratory. Team leader and line management experience of five direct reports. Hands-on experience on worldwide submissions in EU, US, ROW etc.

Career Summary
Jun 2015 – Present
Global Regulatory Affairs Manager EU, ABC Pharma
London, UK

  • Provide an overview of the position and your specialisms. NB: the use of the term ‘global’: companies mean the full life cycle of Regulatory Affairs management of a product, or the pre-marketing, marketing authorization and post-marketing management all together.

  • CTA / IND - it is really useful to list the product (small molecules / OTC / Generics), dosage (tablets, injectables etc.), the phases of development (I, II, III, IV), therapeutic areas (Oncology, CNS, …) that you have worked on.

  • Individual contributor or team leader? Mention any people management experience (team leader of x people).

  • It is important to know on which markets you work, EU, US etc[LR1] . Are you an active contributor in designing the submission strategy or are you the point of contact with the Health Authority?

Nov 2012 - Jun 2015 
CMC Regulatory Affairs Manager US, XYZ Biotech
Boston, MA, USA

  • Keep using the same format. The more information the better, especially technical elements such as the products you have experience on and of which type. Biologics and Biosimilars, in the form of Proteins, Cell Tissues, Vaccines. If you write for CTA submissions, as above, then details about products, phases and TA are extremely valuable.

  • Outline the tasks that you perform: for example, are you an author, do you write CMC/Module 3? 

  • Add information about your involvement in projects to relocate production/manufacturing sites.

  • If you are the line manager of people reporting directly to you, mention the size of your team, and if you have been involved in assessing, coaching, mentoring, recruiting and training.

Aug 2009 - Nov 2012
Regulatory Operations Manager, PharmaGlobal Ltd.
Paris, France

  • Your CV must reflect the technical nature of your role. State whether you create XEVMPD within the RegOps or if you’re an expert in submissions systems for eCTD and NeeS.

  • Use as many industry ‘buzzwords’ as you can to make your CV glow. RegOps hiring managers will look for evidence of tools used.

  • What validation tools do you use? Make sure you highlight these keywords while describing your processes and tasks. For example, EURs, eValidator, FAGGeCTD Checker; if you develop, compile and validate eCTD and NeeS include MAAs, PSUR, amendments, variations, renewals; if you submit via CESP, if you are working to implement new processes like IDMP.

  • Technical environment: since your CV is highly technical, I recommend you list all the tools and methodologies for every job you’ve had (as IT developers do) at the very end of the ‘experience’ section), so XeVMPD, IDMP, eCTD, NeeS, EURs, eValidator, FAGGeCTD Checker, Liquent, Aris Global etc.

Education
2008, PhD in Cardiology & Gastroenterology, Columbia University NYC, USA
Thesis on Nitric Oxide in muscle cells - Cardiology & Gastroenterology.

  • Include details about your academic background, your thesis/dissertation, research (and PhD, MsC, BSc).

I hope you found this useful and if you have any questions, don’t hesitate to email me or call me on +(44)020 7002 0230.


Marcella Marzona
Consultant - Regulatory Affairs
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