Amit Kumar Das

• The Regulatory Excellence Centre (REC) is Merck's global hub designed to harmonize and centralize regulatory execution with efficiency and scalability. This center integrates critical functions, including Established Product Management, International RA, CMC, Operations, Labeling & Ad-Promos, IDMP, Business Intelligence, and Regulatory Data Analytics
• Strategically planned and executed growth initiatives for Regulatory Healthcare business in India/ Bangalore
• Recruited and built strong, cohesive team of like-minded, highly skilled 185 professionals
• Fully embodied and championed organization’s core values
• Seamlessly collaborate with global stakeholders and other strategic hubs
• Streamlined operations by repatriating vendors and internalizing critical work
• As an active member of the organization's POSH committee, I am dedicated to fostering a safe and respectful workplace by upholding the highest standards of prevention, addressing concerns with empathy, and ensuring a culture of zero tolerance towards harassment
• I actively champion CSR initiatives, driving impactful programs that align with our values and contribute meaningfully to the communities we serve

Established Regulatory Excellence Center (REC) from scratch

• Coordinate between Biocon sites, CMOs and CROs for technical, financial and legal documents
• Track and manage dossier preparations for US-FDA, EU/MHRA and RoW submissions
• Status reporting and updates to senior management for monthly, quarterly and board meetings
• Manage contracting, legal, financial and technical correspondence with national and international consultants
• Content management for website

• Joined Kinapse team in 2008 as pioneering regulatory professional when organization was compact 35-member team. Leveraged opportunity to gain multifaceted expertise across diverse business areas, including Regulatory Affairs, Medical Writing, Pharmacovigilance, Quality Management, Audits, Consulting, and Business Development. Played pivotal role in building and scaling regulatory team, driving its growth to over 200 members across multiple locations
• Member of GRA LT and represented GRA in India Leadership Team (ILT) to formulate and implement management decisions and smooth functioning of department within Kinapse India offices
• People Development Group (PDG) Lead for group of 10 members for their professional development, coaching & mentoring, training, appraisals, conducting team building & bonding activities, providing ‘listening ear’ and support for members with personal or other concerns that are impacting their performance at work.

• DrugWrite is Indian subsidiary of Science-First, New Jersey
• Writing Manuscripts, Abstracts, Posters, Oral presentations, Product monographs etc.

• Write Abstracts, Posters, Oral presentations, Product monographs, etc

• Preparation and validation of clinical and non-clinical databases for National and International clients
• Assisting the preparation of dossiers, CTA, Import & Export submissions to DCGI and DGFT
• Maintain study specific project documentation
• Updating company's website
• Preparation of PowerPoint slides and posters for company and clients