Regulatory support, pharmacovigilance and CMC are focal zones contributing both to a company’s sustainability and to its success on the pharmaceutical market. Biotech is, after all, among the most tightly regulated and fiercely competitive fields of the national economy. A thorough mapping of the regulatory landscape is an ongoing need both in small startups fresh from their seed rounds and for established generics manufacturers. The more fluid and changing the global economy – for example, in the wake of Brexit – the more important it is for UK companies seeking to establish themselves in the EU to know their way around. This is where Arex Advisor, a consultancy based in Stockholm, Sweden, comes to help.
In the course of only one year Arex Advisor has grown from four to more than 20 employees. Our newest team member is Minh Pham, Senior Consultant in Regulatory CMC. He has an MSc in Formulation (Biotechnology and Biopharmacy), and also in International Strategy and Marketing. He previously held roles at Galderma and Astrazeneca, most recently as Global Regulatory CMC Manager.
Introducing Minh, we asked him a few questions about his career choices and sources for inspiration.
I: Minh, What inspired you to pursue a career in Regulatory and CMC?
Minh Pham: It is a good combination of my background in life sciences and marketing. I get to be the spider in the web, interacting with a lot of people/functions within a pharma company. As the regulatory framework is a fast-paced environment, I appreciate the daily mixture of strategic thinking, risk-based decisionmaking and problem solving.
I: What was the most challenging and inspiring project you have had, until now?
I led a 2 year CMC regulatory submission project for the addition of a new drug product manufacturing and packing site in an EMEA country. I ensured that the two step CMC variation was delivered according to project timings but also managed all the Health Authority queries to gain approval in time and avoid any delay in the manufacturing and supply plans. In this project I exhibited entrepreneurship and play to win values, bringing structure and certainty to the project, showing respect and resilience to managing the high number of challenges from diverse stakeholders.
Find out more about Minh Pham and our other experts at Arex Advisor's homepage. Arex offers strategic advice and operational support in pharmaceutical research and business development. Our mission is to help leaders and companies bring their projects to commercialization. We are passionate about the development process, leading to submission and a successful commercialization of important medicines – which ultimately helps to improve the lives of patients.
Linda Thunell, tel +46 (0)8 519 345 02