Vatsala is a Manager, Regulatory Affairs at Regulis, responsible for supporting medicinal product registrations and lifecycle maintenance in European countries and the US. Additionally, Vatsala plays a key role on medical device projects for clients with her growing technical knowledge and writing skills.
Value to clients
An education in Pharmaceutical Sciences provides Vatsala with a strong scientific background which she applies to her work. Her attention to detail and communication skills ensure that she delivers to meet the needs of our clients in a timely manner.
- Experienced in CTAs, MAAs and post approval activities. As our “variations expert” Vatsala’s expertise with post-approval activities ensures licences are efficiently maintained and in compliance
- Analysing non-clinical and clinical data to generate high quality regulatory summaries and overviews
- Experience in creation and management of device technical files, literature searching and clinical writing
- Skilled in presenting manufacturing information in the module 3 of registration dossiers
Following the completion of her BSc(Hons) degree, Vatsala joined Regulis as a Research Intern. Initially, she was responsible for performing a range of drug safety activities including case processing, review and submission of aggregate reports. After joining the regulatory affairs team, Vatsala demonstrated a natural flair for regulatory affairs and consistently performed above her job specification, quickly progressing to Senior Regulatory Affairs Executive and now Manager. In the 4 years Vatsala has been at Regulis, she has worked on various pharmaceutical and medical device projects thereby strengthening her expertise and broadening her knowledge in both fields.
Other things about Vatsala
- Twice short-listed as a finalist for the TOPRA Horizon Award for Regulatory Excellence
- Has hands on pharmacovigilance experience
- Avid volunteer of a children’s charity