My career in Regulatory Affairs; Angela Miller, Director, Global Regulatory Affairs – Oncology, Eisai

Angela Miller, Director, Global Regulatory Affairs – Oncology, Eisai

In the first of emedcareers’ series of interviews with some of the movers and shakers in the pharmaceutical sector we’ve spoken with Angela Miller, Director, Global Regulatory Affairs – Oncology, Eisai about her career experiences in Regulatory Affairs and asked her for her insider view on the jobs market.

1. What was your own career path?

At junior school I always wanted to be an English teacher. At secondary school it became evident that science was something I excelled at and enjoyed, so it was natural that I did a degree in chemistry and mathematics. After my degree I started work at a small chemical company before moving to Baxter Healthcare where I was spotted in the chemistry lab and asked to join the Regulatory Affairs department. Once I had discovered what Regulatory Affairs was, I decided that I needed to increase my knowledge and enrolled on a taught MSc in Pharmacology and Toxicology which I completed whilst working on a half day release basis. Since then I have worked for CRO’s, start up pharma companies, device companies and large pharma companies and have now worked in regulatory affairs for about 20 years. So I started at the bottom and have worked my way up!

2. What most attracted you to the role you’re now doing?

I wanted to work in a role where I could play a part in developing new talent and remain in touch with projects. Eisai gave me an opportunity to mentor regulatory affairs professionals and make a real difference by participating on global drug development teams. So I have a great team working for me which is giving me experience in managing a diverse cross section of people whilst also remaining a ‘hands on’ regulatory affairs professional.

3. Why do you think candidates are attracted to working in Regulatory Affairs?

I hope candidates are attracted by being part of a department that plays an instrumental part in drug development from beginning to end. We look after projects from inception, all through development to marketing and beyond.

4. What do you see as the main issues currently facing professionals developing their career in Regulatory Affairs?

Getting a first position in regulatory affairs is always difficult and sometimes getting in through ‘the back door’ is the best way. For example getting a grounding in drug development through being in chemistry or clinical can be a way in to the regulatory affairs department. Once in regulatory affairs, professionals have to realise that progression takes time. There is a lot to learn and it is not only regulations and procedures that have to be mastered, it is also politics, management and seeing the effect that your actions have on projects and other people.

5. What do you see as the main issues currently facing companies looking to recruit skilled employees in Regulatory Affairs?

The biggest problem is that there is a lack of potential employees who are skilled in more than one area of regulatory affairs. Also there is a general lack of personnel with all round drug development experience – some people are good at chemistry, some at SmPC and some at labelling – what is needed is all round experience, especially in small and middle sized companies.

6. What types of candidate seem to be currently most in demand in Regulatory Affairs?

The all round candidate with good general drug development knowledge who is flexible, ready to learn, with good interpersonal skills with a sense of humour is the person of the moment

7. What have been the biggest changes you’ve seen in the jobs market in Regulatory Affairs over the past five years?

There are fewer entry level jobs which is a shame, but it reflects the fact that companies are less able to afford to employ people who cannot “hit the road running”. It seems that the senior level jobs still have an element of ‘hands on’ work as well as people management which is good as most senior level people I know do not like to lose that element of their job in favour of people management alone.

8. How do you see the jobs market in Regulatory Affairs changing over the next few years?

I think that companies will start to employ more entry level candidates again as long as the economy picks up.

9. In what areas do you see the UK jobs market in Regulatory Affairs being most impacted by changes in Europe and other international markets?

I think there is already a tendency towards regulatory affairs departments becoming global entities. I think this will continue especially if legislation becomes more global. So there may be more opportunities for UK professionals to take positions overseas and vice-versa.

10. How do you relax outside work?

I play far too much golf! But I also enjoy horseracing and breeding and racing greyhounds. The best thing about golf is that it gives me three and a half hours away from any mobile phone or blackberry interruptions! I have grown up with horses and dogs around me so they were always going to play a large part in my life. Luckily most of my close friends share the same interests so my hobbies tend to be a huge part of my social life.