As we expand our Regulatory Affairs team, learn how Accelagen is enhancing expertise in regulatory strategy, market authorisation, and patient impact.

Accelagen’s reputation as a leader in clinical research was established, at least initially, through the expertise and foresight of CEO and Managing Director, Greg Plunkett. However, over time, our ability to navigate the complexities of regulatory approval and market authorisation has been strengthened by a growing team of experts in their field. As the team continues to grow, we’re proud to introduce you to one of our newest Regulatory Affairs Officers, Adriana Paola Camargo (Paola). 

What is Regulatory Affairs and why does it matter?

The way we see it—Regulatory Affairs is where science meets strategy in bringing new therapies to patients. It’s the process of ensuring that medical products—whether it’s drugs, biologics or devices—meet stringent safety, efficacy, and compliance standards before getting to market. Expert regulatory oversight ensures that life-saving treatments reach patients as efficiently and safely as possible. And it’s this patient-first approach that is central to the way we operate at Accelagen.

At Accelagen, our Regulatory Affairs team is highly skilled in being able to anticipate challenges, streamline approvals, and provide strategic guidance that accelerates market access. Whether it’s dossier gap analysis, market authorisation or lifecycle management, our talented team ensures that every regulatory step is aligned with a sponsor’s clinical and commercial goals.

Strength in leadership, bolstered by teamwork

Joining the team in May 2024, Paola Camargo knew she had stepped into a dynamic and highly experienced team from the very beginning. 

Backed by our Head of Regulatory Affairs & Quality Assurance, Sarah Henderson, and Regulatory Affairs Manager, Daniela Velandia, Paola is part of a proudly women-led team that has successfully gained market approvals across Australia, New Zealand, the US, Europe, and South America. With extensive expertise in pharmaceutical regulations and market authorisation, this team has built a reputation for cutting through complexity and delivering results. 

With her background as a pharmacist and in-depth knowledge of regulatory frameworks, Paola adds valuable expertise and enthusiasm to the team. Originally from Colombia, she has spent the past six years in Australia learning the ins and outs of the pharmaceutical industry here. In her role, she supports document management, validation processes, and ensuring submissions meet the highest standards before reaching bodies such as the Therapeutic Goods Administration (TGA). 

“As a pharmacist, my passion has always been to contribute to the industry in a meaningful way—to help patients, especially ones with rare diseases that are difficult to treat. Joining Accelagen has given me the opportunity to work on projects that directly impact patients, so that essential medicines reach those who need them.”

Looking ahead to the future of Regulatory Affairs at Accelagen

Regulatory Affairs has been integral to Accelagen from the very beginning, shaping our expertise and reputation. It’s where our expertise began, and it remains a key differentiator in how we support our clients. But there’s always more to learn, and that’s what excites Paola about joining the Accelagen team.

“The field of regulatory affairs is evolving rapidly, and I’ve already seen how Accelagen stays ahead of the curve by embracing technology and efficiency. It’s an exciting time to be part of this team.”

With the addition of people like Paola and the continued leadership of our senior team, we’re proud to say Accelagen’s Regulatory Affairs division is stronger than ever.

Want to learn more about how Accelagen’s Regulatory Affairs team can support your clinical and commercial goals? Get in touch with us today ↗