Rajib Kumar Baishnab

Rajib Kumar Baishnab has extensive experience in the field of global regulatory affairs. Rajib Kumar started their career in 2009 with an internship at Orion Pharma Ltd, where they gained experience in various areas such as production, quality assurance, research and development, and product management.

In 2011, Rajib joined Comprehensive Healthcare Limited as a pharmacist before moving on to Square Pharmaceuticals Limited as an Executive in global regulatory affairs. During their time at Square Pharmaceuticals, they were responsible for preparing technical dossiers, submitting regulatory applications to USFDA, and ensuring compliance with regulatory requirements.

In 2016, Rajib joined The ACME Laboratories Ltd. as a Manager in global regulatory affairs, where they managed and coordinated a team of regulatory staff. Rajib Kumar actively contributed to the development and implementation of regulatory strategies and provided support for new and existing products.

Rajib then advanced to the role of Sr. Manager and Assistant General Manager, where they led and drove all submission activities and coordinated regulatory procedures and operations within the company's product portfolio.

Overall, Rajib Kumar Baishnab has demonstrated a strong background in global regulatory affairs, with expertise in managing teams, developing regulatory strategies, and ensuring compliance with regulatory requirements.

Rajib Kumar Baishnab has a B.Pharm degree in Pharmacy from the University of Science and Technology, Chittagong. Rajib Kumar also holds an M.Pharm degree in Pharmacy from the State University of Bangladesh. Prior to their university education, Rajib attended Chittagong Cantonment College where they completed their H.S.C. degree in Science. Rajib Kumar also attended Chittagong Govt. High School where they completed their S.S.C. degree in Science.

In addition to their formal education, Rajib Kumar Baishnab also has several certifications. Rajib Kumar obtained a certification in Good Clinical Practice (GCP) from The National Institute on Drug Abuse (NIDA) in August 2021. Rajib Kumar completed a course on ISO 14001:2015 Lead Auditor certification from Intertek in November 2020. In September 2019, Rajib obtained a Certification on KPI Master Class from Savvy Consultants Company Limited. Rajib Kumar also received training in Coaching for Results from The ACME Laboratories Ltd. in August 2019.

Moreover, Rajib Kumar Baishnab participated in a workshop on Quality by Design (QbD) and Lean Six Sigma in Pharmaceutical Product Development organized by QbD-Expert™ in August 2019. Rajib Kumar attended a 5-day International Pharmacovigilance Training & Workshop conducted by PVCON CONSULTING in February 2017.

Furthermore, Rajib obtained several certifications related to FDA regulations and pharmaceutical industry practices. Rajib Kumar completed workshops and courses on topics such as USFDA filing and approvals, electronic submission of Drug Master Files (DMFs), and the implementation of Generic Drug User Fee Amendments (GDUFA). These certifications were obtained in 2016 and 2015 and were provided by institutions such as FDA and Raj GPRAC.

Overall, Rajib Kumar Baishnab has a strong educational background in pharmacy, which is complemented by various certifications and trainings related to pharmaceutical industry practices and regulatory compliance.