Dr. Rajashree Devarakonda as Vice President, India and Asia Pacific Operations has a global strategic, business development as well as operational role within Voisin Consulting Life Sciences. She manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics; and as Head, India and Asia Pacific Operations, she oversees the operations of VCLS’s office in India.
She brings her 20 years of broad experience working various senior management positions in industry and academic positions from US, Canada and in India in medical, clinical trials and regulatory activities with a focus on European and US development.
Rajashree specializes in; strategic partnerships, business development, client relationships, projects involving global regulatory strategy, preparation of regulatory road map, medical and safety/efficacy review of various documents, gap analysis of clinical trial and marketing authorisations applications (MAA/NDA/IND/CTA) at various stages, assistance with Scientific advice / pre-IND meetings briefing packages and liaison with regulatory agencies.Rajashree has received training in advanced clinical trial design from Canada and works extensively in clinical trial protocol design, clinical development plans. Rajashree is also responsible for providing medical and regulatory input for safety efficacy and pharmacovigilance activities including Risk Management Plans for various products.
In addition, Rajashree also has significant experience in GCP, scientific writing, has extensive training/experience in clinical areas, has lead and managed various activities of clinical trials from design to implementation, has written several major international multi-center team grant applications, has managed several industry trials, supervised and line managed several research groups and was involved in major consortiums applications to standardize clinical research across Canada.
Rajashree has been a speaker at several national and international conferences including at DIA and also is part of several industry associations and has published several articles.
Rajashree received her Bachelor’s degree (MBBS) from the Karnataka Medical College, Hubli, India as a Medical practitioner in 1994. As part of her masters’ program, she received her training in Molecular Biology/Immunology at San Jose State University, California, USA. She then went to Vancouver, Canada and later on to Oxford, UK as a part of her research thesis (Hypertension in Pregnancy) and got her master’s degree (MSc.) from University of British Columbia, Canada. Rajashree has completed EGMP (Executive General Management Programme (MBA)) from IIM Bangalore, India.
Rajashree is RAC ( Regulatory Affairs Ceritification) Certified from RAPS (Regulatory Affairs Professional Society, USA), She is CCRP (Certified Clinical Research professional) certified from SOCRA (Society of Clinical Research Associates, USA). Rajashree received her various Regulatory certificates in Pharmaceuticals from RAPS for European, American, Canadian and Global Regulatory Areas for Drugs and Biologics. Rajashree is a member of Drug India Association (DIA), Regulatory Associates Professionals (RAPS), Society of Clinical Research Associates (SOCRA), International Society of Research Administrators (SRA International), Canadian Clinical Research Respiratory Consortium (CRCRC) and Karnataka Medical Council (KMC) among many others.