This month we speak with Dr. Lorraine Marsh, Head of Scientific Affairs at Fusion Pharma, about her career highlights, her advice for graduates looking to start a career in Regulatory or Scientific Affairs and much more!

1. Do you have a career highlight, a moment that stands apart, working within your field of expertise within Regulatory/Scientific Affairs?

There have been so many highlights during my 25 years in the pharmaceutical industry…

Receiving my doctorate in Pharmaceutics for collaborative work with Reckitt on bacterial adhesion in 2001; Chairing and speaking at several TOPRA conferences – both in the human medicines and veterinary fields; Performing honey bee hive inspections when working on the development and licencing of ectoparasiticides for honey bee health for Vita Europe; Preparing an oncology manufacturing site for successful FDA inspection; overseeing an MHRA inspection and contributing to many more.

Perhaps one of my most memorable is submitting my first dossier for Bayer nearly 25 years ago: I remember booking the delivery and the mail woman turning up and taking in the site of literally hundreds of Lever Arch files piled up high in the document prep room, yep in those days dossiers were all hard copy. She came back with a wooden pallet on wheels and together we loaded the application onto the contraption and made several trips to the mail room. It was huge!

But my most satisfying and exciting highlight has been joining forces with my long-time friend and regulatory partner-in-crime Leah Heathman – founder of Fusion Pharma. Over the last year I have been involved in many areas of the business – some new to me – such as writing content for the new website, developing the Fusion Brand, writing blogs, working on purposeful collaborations, brainstorming and working on new campaigns such as our Complimentary Brexit Overview and many more projects.

I can’t wait for the adventure to continue!

2. Do you have any tips for graduates looking to start their career within Regulatory/Scientific Affairs?

If you want to use your solid scientific background to contribute towards ensuring the Safety, Quality and Efficacy of medicines and devices in the pharmaceutical industry then my top tips would be to simply start working for a pharmaceutical company and have an enquiring mind, a willingness to learn and be ready to read around your subject to understand and keep up to date with the regulatory intelligence in your area.

Be flexible in your professional development; soaking in as much on-the-job-training, courses, webinars, and conferences as you can. Learn how different areas of the pharmaceutical dossier impact on each other.

Get experience in settings other than Regulatory Affairs if you can e.g. spend time in the areas of pharmacovigilance, medical information, quality, sales and marketing, business development, R & D and manufacturing.

Be a team player. Understand that Regulatory Affairs is a collaborative career working across and impacting the whole pharma business. Sharing your input on regulatory strategy together with understanding the needs of the business are essential to the successful lifecycle of a pharma product. Take pride in creating well constructed regulatory submissions and liaise effectively with your agencies.

3. What are the three things you have learnt about the industry which you feel would be beneficial for other regulatory professionals to know?

In Regulatory Affairs you are playing the Long Game. Think about making your original submission as future-proof as possible by building in flexibility into your dossier. Consider how best to incorporate future changes into any submissions you are preparing now.
It’s all in the timing! Be conscious of how your submissions impact on other areas of the business eg manufacturing, packaging, marketing etc. and work together with all stakeholders for successful outcomes.
It’s an inexhaustible field. No one can be an expert in all areas of Regulatory Affairs. It covers a vast treasury of information so don’t be afraid to step out of your current niche area to discover the myriad of regulatory delights which are out there!

4. What do you believe sets Fusion Pharma apart from other pharma consultancies?

At Fusion Pharma we have a wonderful close-knit team who support each other’s well being as well as our continuing professional development. This is an excellent place from which to start to then extend this commitment to exceptionally high standards onto our clients.

5. What is your favourite thing about working for Fusion Pharma?

My favourite thing about working for Fusion Pharma is the refreshingly positive attitude of our Founder and Managing Director, Leah Heathman. Her commitment to supporting her staff and her vision for the company is reflected in all her carefully-thought-out policies, communications and actions.