Regulatory affairs is the interface between the pharmaceutical company and the regulatory agencies across the world. A regulatory agency (UK= MHRA and Ireland =HPRA) is the competent government agency which is responsible for ensuring that medicines work and are acceptably safe.
I maintain Marketing Authorisations in UK and Irish Markets and act as interface between GE Healthcare Ltd and MHRA and HPRA. I prepare national specific documents in support of GE applications to agencies.
I draft product labelling & leaflet texts in line with current legislation and gain MHRA and HPRA approval of artworks.
1. To what extent did you enjoy your work placement or internship?
Really enjoyed it overall. Very good experience of work in regulatory affairs, supportive manager and HR, friendly colleagues. The location was slightly difficult to get to and didn't offer much to do at lunch time or after work - quite secluded.
2. To what extent did you feel valued by your colleagues?
My manager and close team often praised me for my work however I felt that other interns who did less work than me often got recognised for awards whereas i didn't. This may however been due to the fact that my manager was new and therefore wasn't as aware of the rewards scheme. I also worked with a lot of contracted employees who we're able to give out rewards.
3. To what extent were you given support and guidance by management/your supervisor(s)?
Excellent manager who gave me appropriate guidance and support whilst also challenging me. She allowed me to have inductions with other people in the business so that I could gain a greater understanding of how a pharmaceutical company works. Lots of opportunity for personal development and gave me a feeling of achievement.
4. How busy were you on a daily basis?
Was very busy with work most of the time however it fluctuated and often depended on other people doing their bits of work first. Always playing catch up and working to meet deadlines so need to prioritise and stay organised. My manager did a very good job of regulating my work load so that I wasn't ever overloaded.
5. How much responsibility were you given during your placement?
As my manager hired me to help with her own workload, I was given a lot of responsibility and got involved in a lot of the work my manager did (not just admin). She believes that I could easily work as her deputy after another year of working here. The only things i couldn't get involved in were tasks that could directly lead to the company getting into trouble with if they were done incorrectly.
6. To what extent did/will the skills you developed, and training you received, assist you in your degree studies and beyond?
I have gained many skills including:
RA specialist knowledge and regulations
Pharma business knowledge and different roles involved
Product and biological knowledge
Independence and confidence
Proactive, initiative and taking ownership
Problem solving and research skills
Prioritisation, time management and self-organisation
Precision and accuracy
IT skills –Word, PDF, Excel, Outlook
Verbal communication - Assertive, Networking skills, Presentation skills
Written communication - Professional, Persuasive, Influencing skills, Clear and informative
7. What was the general atmosphere in your office?
Everyone was very friendly however it was quite quiet and people stayed at their desks most of the time. Probably because i was working in regulatory and alongside R&D who all need to be quiet and concentrate. The actual office was nice and big though so got to meet a lot of new people.
8. How well organised was the overall work placement or internship set up?
It was organised well at the beginning with lots of induction events and emails from HR however we received less contact after the first few months . We did, however, still have monthly intern catch up calls was and social media pages were used to update us on what other interns were doing. Some internships were more structured than others. I had a well organised placement as my manager has a real need for an intern to help with her workload.
9. In terms of personal training and development, to what extent did the company or firm invest in you?
We all received online training from the company and went to a new employees event which allowed us to network with other new employees within the company. I personally received a lot of valuable training from my manager and was given lots of opportunities for personal development.
10. What were the perks on your work placement?
Staff Sales/Staff Shop
Working from home
11. How appealing are future employment prospects within the organisation?
There are some graduate programmes available however there isn't one for regulatory.
12. Was there a good social scene amongst any fellow placement students/colleagues?
Yes, there were a lot of interns working across the 3 sites in Amersham. I've made some good friends who I go out with regularly after work/ at the weekend.
13. What was the cost of living and socialising in the area you worked in?
As I lived at home in watford, I didn't have to spend much on living costs and socialising wasn't too expensive.
14. What was the Nightlife like in the area you worked?
The nightlife is quite tame. There are some pubs and nice restaurants but if you wants bars and clubs you'd have to go to Watford or central London. I lived at home in Watford so I was still able to go out in the evenings. I would definitely recommend living in Watford or somewhere along the metropolitan line closer to Central London.
15. Were there many opportunities to get involved in activities outside of work?
Not really. They have some gym classes and charity events but other than that the interns were left to organise events amongst themselves