Jonathan Evans Email & Phone Number

Auckland, New Zealand

Auckland, New Zealand

My position involves the registration of generic dosage forms, and subsequent dossier maintenance, in multiple regions including New Zealand, Australia, Europe, Asia and the Americas. Although reporting to the Director of Regulatory Affairs, the seniority of my role requires that I work autonomously and with limited supervision.This position has utilized my strong communication skills in liaising effectively with regulators in New Zealand and overseas, and also with numerous development and quality departments both in-house and externally with partner-companies. The role has drawn on my technical and professional knowledge, and my ability to work under pressure to meet deadlines. The tracking of registration and variation approvals has required attention to detail and careful planning. I have also invigilated as the company representative in six bio-equivalence studies in both NZ and overseas. I am a current Health & Safety Representative and First Aider for the company.

Auckland, New Zealand

Auckland, New Zealand

My position involved project management responsibility for the development of generic dosage forms in compliance with EU and FDA regulatory guidelines. I was responsible for managing a number of projects simultaneously, prioritising workloads and allocating resources appropriately to meet deadlines. I have been involved in developing numerous dosage forms: high potency tablets, steroids, nasal sprays, hard gelatin capsules, and controlled release medicines. I undertook considerable formulation development work to obtain final formulations comparable to the innovator product. My role required advanced analytical chemistry skills to develop and validate analytical methods for both drug substance and product. I was also required to write analytical and product development reports to ICH, EMA and FDA guidelines to publishable quality. I also supervised a number of Research Associates and Analysts, co-ordinating their work, coaching and problem-solving.

Auckland, New Zealand

This role involved a six month placement in Research & Development and a six month placement in Regulatory Affairs.

Doctor Of Philosophy (Ph.D.), Pharmaceutics

Bachelor'S Degree, Pharmacy