What’s regulatory affairs all about?

C+D chats to Rabiea Abdullah about how community pharmacy has shaped her career in the pharmaceutical industry and led to her own regulatory affairs consultancy business...
What’s regulatory affairs all about?
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As community pharmacy awaits the outcome of the 2024/25 and 2025/26 community pharmacy contractual framework (CPCF) negotiations, many may be wondering what the future lies ahead as the sector faces a critical moment after years of funding cuts and pharmacies closing. 

But C+D spoke to one pharmacist who has carved a career path outside of community pharmacy in the pharmaceutical industry, as she shares how her experience in community has helped her to thrive in her regulatory affairs career. 

From locum shifts to the MHRA 

Rabiea Abdullah studied the MPharm at UCL and did her pre-reg in community pharmacy before locuming. 

“I really enjoyed it, but I felt a bit unsatisfied because I wasn’t able to do certain aspects of my degree which I really enjoyed,” she says. 

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Abdullah enjoyed studying drug discovery as well as pharmaceutical analysis and drug development, so she started to explore how she could continue working and learning about these parts of pharmacy. 

“I was reading C+D and there were articles from people from different areas of industry, and I realised there’s different opportunities available,” Abdullah says, and this led her to regulatory affairs. 

She enjoyed linking “scientific knowledge we’ve gained from university” to regulations and this led to positions where she worked on small molecule, biological and gene therapy regulatory submissions across clinical trials, commercialisation and post-approval stages. 

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Abdullah’s first regulatory role was with the MHRA where she gained a lot of expertise in a short amount of time, as well as understanding the “very big responsibility” she had in assessing applications for medicines to be approved in the UK. 

But on the other side of working for a health authority checking for the quality, safety and efficacy of medicines applying for marketing authorisations, she began working on the other side of the regulatory affairs industry with companies like MSD, Bayer and GSK to lead regulatory submissions and strategies. 

“That was really exciting because it’s more about understanding what goes into the submission, all the data and working with other people."

Consultant and course leader 

Abdullah says she does miss the direct patient interaction that community pharmacy offers but likes the “wide impact” you have working on regulatory affairs impacting all patients. 

“The one-to-one interaction is not there, but pharmacists are well placed to work in regulatory affairs because they had that direct interaction with the patient. And not all regulatory affairs professionals have that link so by having that knowledge or interaction with patients, you always put the patient first naturally.” 

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She admits it’s hard to get into regulatory affairs but the payoff has been worth it. 

“I applied for 80 jobs before I got into the MHRA but I didn’t give up because I knew this is something I’m really passionate about. At the end of it, I got a rewarding career, so we have to go through hardships to pursue career paths we want to do”. 

Abdullah now has gathered enough experience and works primarily in regulatory consulting which she started six years ago and then launched Advance Regulatory Consulting. She works across anything from gene therapy cancer vaccines in clinical development to marketing authorisations for complex biopharmaceuticals. 

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In 2022, she also established her own training business Entry To Regulatory and runs courses supporting people wanting to get into the regulatory affairs industry. 

“I reflected on my journey and thought how can this process be made easier? That’s why I developed this course. 

“I’ve been working in this field for over 10 years now and there’s a lot of variation, but I still feel that it challenges me and there’s so much to learn.” 

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Go to the profile of contact@entrytoregulatory.com
about 1 month ago

Thanks Ben for the post.

If you want to get into regulatory affairs and get work experience:
https://www.entrytoregulatory.com/how-to-get-a-job-in-regulatory-affairs

If you want to learn about regulatory affairs for free!
https://www.entrytoregulatory.com/regulatory-affairs-courses 

Follow me on LinkedIn: www.linkedin.com/in/rabiea-regulatory 

Rabiea