What is your job position and how would you define it?

I am a regulatory affairs specialist. My goal is to make sure that products comply with regulatory requirements set by government agencies such as the FDA, Food and Drug Administration in the United States, the EMA, the European Medicines Agency in Europe, and other regulatory bodies worldwide.

This includes reviewing and interpreting regulations, preparing, and submitting regulatory dossiers, and communicating with regulatory agencies to facilitate the approval process for new drugs or the maintenance of existing ones. Additionally, I may provide guidance to internal teams on regulatory matters and monitor changes in regulations to ensure ongoing compliance.

When does your expertise come into the product’s life cycle? 

Most of the time, I am working with products that are already approved. The Marketing Authorization has been granted and a change needs to be made, such as new indications, formulations, or manufacturing processes. I ensure that any changes are implemented in compliance with regulatory requirements.

Why is your job position relevant at Aixial Group? 

Regulatory approvals are mandatory for pharmaceutical products to be marketed and sold. By navigating the regulatory approval process, I help companies gain market access for their products, enabling them to reach patients in need and generate revenue.

How does your job or area of expertise stand out in the life sciences industry? 

CROs typically offer a range of broad services, including clinical trial management, drug development consulting, and regulatory affairs.

This model allows regulatory specialists to collaborate closely with other teams within the CRO, such as clinical operations and scientific experts, to provide holistic support for clients’ drug development programs.

What are some current and future challenges or trends impacting your area of expertise? 

Regulatory agencies are collaborating to harmonize regulatory standards and streamline regulatory processes to facilitate global drug development and market access. Initiatives such as IDMP Identification of Medicinal Products aim to standardize the identification, coding, and exchange of information about medicinal products.

While IDMP Identification of Medicinal Products was initially developed by the European Medicines Agency, its principles and standards are being adopted by regulatory agencies worldwide as part of broader efforts to harmonize regulatory requirements and improve the safety, quality, and availability of medicinal products globally.

How is Aixial staying at the forefront of innovation?  

This may involve implementing quality management systems, process optimisation initiatives, and performance metrics to ensure the delivery of high-quality services that meet or exceed client expectations.