RM

Reena Malik

Associate Director - Regulatory Affairs Strategy And Operation Lead at Q32 Bio

Reena Malik has over 13 years of experience in the field of Regulatory Affairs. Reena started their career in 2008 as a PV (Argus/MedRA) Trainer at Cognizant Technology Solutions. Reena then moved on to become a Team Leader_PV_PBRER/AR medical writer and a Drug Safety Specialist (Data Analyst) at the same company. In 2014, Reena Malik joined Tata Consultancy Services as an Assistant Manager- Pharmacovigilance/ Medical Writing/Clinical Operations. After two years, they moved on to Sanofi Genzyme as a Regulatory Affairs Specialist. In 2016, Reena Malik joined Takeda as a Manager Global Regulatory Affairs. Reena then moved to PRA Health Science in 2017 where they held three roles, namely Sr. Manager Regulatory Project and Submission Management, Manager, Regulatory Project and Submission Management, and Associate Regulatory Submission Manager. In 2021, Reena Malik joined ICON plc as a Sr. Manager Regulatory Project and Submission Management. Currently, they are working as an Associate Director Regulatory Affairs at Q32 Bio Inc. since 2022.

Reena Malik has a diverse educational background. Reena completed their BAMS (Medicine) from Maharashtra University of Health Sciences between 2000 and 2005. Reena then obtained a Diploma in Clinical Research from Clinical Research Education and Management Academic in 2008-2009. Reena furthered their education by obtaining a Master's degree in Project Management with Regulatory Affairs Concenteration from Northeastern University between 2015 and 2017. Reena has also obtained several certifications, such as The Secret to Better Decisions: Stop Hoarding Chips from LinkedIn in 2021, OneNote 2016 Essential Training from Lynda.com in 2018, Project Management Professional from Project Management Institute in 2018, Managing International Projects from Lynda.com in 2016, Managing Project Teams from Lynda.com in 2016, Managing Project Risk from Lynda.com in 2016, Become a Project Coordinator from Lynda.com in 2016, Managing Project Stakeholders from Lynda.com in 2016, Managing Small Projects from Lynda.com in 2016, Project Management Simplified from Lynda.com in 2016, and FDA-eCTD from FDA.

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Timeline

  • Associate Director - Regulatory Affairs Strategy And Operation Lead

    April, 2022 - present

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