Current position and relevant professional experience:
Current Position: Associate Director of Regulatory Strategy UK&IE
Professional Experience (current and previous):
Over 15 years of experience in regulatory affairs.
Current role:
- Lead the development of regulatory strategies for assets early in the pipeline, through to post marketing for both cell and gene therapy products along with small molecules.
- Provide innovative regulatory solutions and guidance to cross-functional teams.
- To understand and translate regulatory, scientific, operational, and business knowledge into effective implementation plans and strategy.
- To be aware of regulatory changes and develop proactive strategy accordingly.
- Member of several workstreams which aim to improve processes and drive efficiencies.
- Regulatory representative within BIA and EMIG trade associations.
- Participant within the MHRA steering group, a MHRA/Industry team responsible for developing guidance in the UK, working with the MHRA to create guidance’s for various changes that are being made in relation to the legislation.
- A Member within the England Rare Diseases Framework Delivery Group.
Previous experience:
- Development of global regulatory strategy for new active substances.
- Clinical trial applications EU, UK, Japan, Australia, and Canada.
- MAA submissions Europe, Asia, Middle East, Canada, and Australia.
- Post marketing experience covering pharmacovigilance and CMC submissions.
- Over 8 years’ experience running my own regulatory consultancy company in which I engaged with and advised various clients on regulatory strategies for products in pre and post development cycles.
Current or previous involvement in TOPRA activities:
I have previously completed my Masters in Regulatory Affairs with TOPRA. This gave me an opportunity to attend various relevant TOPRA courses which I believe have truly enhanced my regulatory knowledge over the years. I have been a TOPRA member from the beginning of my career in Regulatory Affairs and I am fully aligned with the TOPRA organisation mission and values.
Personal statement:
Associate Director in Regulatory Strategy at Vertex Pharmaceuticals, London, UK. Over 15 years of broad regulatory affairs experience covering new chemical entities and ATMPs. I will use my experience to support TOPRA achieve a comprehensive approach to educating regulatory professionals across the industry, extend its footprint, influence and strengthen alongside shaping the future of the organisation. This will also be a great opportunity for me to be able to give something back to a rewarding profession that has given me so many opportunities and to drive my passion in supporting regulatory colleagues who are early in their career to achieve long term success.
Nomination information
Proposer: Sonia Morjaria; Seconders: Tim Stonehouse, Suman Dhir