Current position and relevant professional experience:
I currently hold the position of Vice President- Regulatory Affairs at Dyne Therapeutics, Waltham, Massachusetts, USA. Dyne is focused on rare muscle diseases. I provide regulatory strategy support for the candidates in the R&D pipeline covering Europe and International markets. I am based out of the UK and travel to Boston as and when needed.
I have around two decades of experience in regulatory affairs working small and large pharma/biotech companies including GW Pharmaceuticals (now part of Jazz Pharma), Shire Pharmaceuticals (now part of Takeda), Merck Sereno, J&J, GSK, UCB, Biocon and others where I led the European and International regulatory filing efforts. Over the last few years, my focus has been predominantly in the rare disease space where I believe there is huge unmet need.
I was awarded Fellowship of TOPRA and Royal Society of Chemistry (RSC) for my contributions in the field of science and regulatory affairs.
I was also recently appointed by British Pharmacopoeia Commission (BPC) as Member of the Expert Advisory Group (EAG) where I get to work closely with BPC and MHRA team members.
I have been an active member within EFPIA (European Federation of Pharmaceutical Industries and Associations), a EU Trade Association by being part of the IREG (International Regulatory Expert Group) committee and the Chair of the EFPIA India regulatory network for many years. As Chair of the India regulatory network, I represented EFPIA in many high level regulatory dialogues between European Commission (EC)/European Medicines Agency (EMA) and Indian Ministry of Health (MoH) on emerging and regulatory topics impacting the industry.
I am currently representing Dyne at EUCOPE (European Confederation of Pharmaceutical Entrepreneurs), Europe's trade body on matters relating to Scientific Advice, Orphan applications and transition to Clinical Trial Information System (CTIS). As part of EUCOPE, I have had the opportunity to participate in bilaterial discussions between the EMA and the industry on R&D and regulatory topics. I also helped EMA as EUCOPE representative pilot their paediatric submissions into the IRIS portal.
Outside work, I do lot of mentoring activities supporting young children at local schools. I am also a Board member and trustee at two of the local secondary schools.
Current or previous involvement in TOPRA activities:
I have been a TOPRA member since March 2009. During this time, I chaired the TOPRA CMC CRED workshop. I have also been part of CMC SPIN committee in the past.
I would like to partner more closely with TOPRA as not only I see this as an opportunity to give back and contribute to the good cause but also help TOPRA in shaping the future of regulatory affairs not just in the UK but globally and help as many professionals as possible who are either new to regulatory affairs or are considering a career in regulatory affairs.
Personal statement:
In my industry career of over 25 years, I have been able to closely partner with many key stakeholders from the industry and health authorities on key topics of mutual interest.
If elected to serve as President-Elect, I would like to further strengthen and extend TOPRA's current reach and connectivity globally to help regulatory professionals in the different geographies benefit from the excellent support and guidance TOPRA is providing in terms of training and career development.
I also plan to identify opportunities to partner with other bodies such as industry associations on topics of mutual interest thereby maximising resources and elevating TOPRA's visibility.
Nomination information
Proposer: James Crawforth; Seconders: Sanyam Gandhi, Rashi Sharma