Mark Pellett

WORK HISTORY

EDUCATION

SKILLS

ABOUT MARK PELLETT

A pharmacist with a PhD in topical and transdermal drug delivery, and an MSc in Information Technology. • Preparation of Regulatory CMC strategies and their execution for global markets. • Extensive management of contractors and generation of CMC data for licence applications. Developed CMC strategies, authored Modules 3’s and QOS’s, and successfully lead Agency meetings for both pre- and post-approval products.• Experienced in developing products including- Identification, evaluation and demonstration of proof of concept for new product opportunities- Leading global project teams in a matrix environment integrating the overall product development strategies for CMC, regulatory, clinical and delivering market claims.• Developed and launched a range of different formulations including soft gelatin capsules, tablets, syrups, effervescent tablets, topical gels and sprays, suspensions, and nasal sprays. • Successfully managed CPs, DCP\'s and MRPs from initiation to conclusion; multiple national filings and provided regulatory strategy for variations. • Managed teams of up to twelve members of staff, which involved coaching, mentoring, appraisals, managing projects and resources. • Leading a section of 60 members of staff providing and implementing creative regulatory CMC strategies for biologic programs and championing reliance and inter-agency collaborations.