Amit Kumar Das Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Ka, In

Bengaluru, Karnataka, India

- Streamlined operations by repatriating vendors and internalizing critical work.- Ensured business stability and maintained seamless continuity of operations (BAU)- 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… Show more - Streamlined operations by repatriating vendors and internalizing critical work.- Ensured business stability and maintained seamless continuity of operations (BAU)- 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. Show less

Bengaluru, Karnataka, India

The Regulatory Excellence Centre (REC) is a global hub designed to harmonize and centralize regulatory execution with efficiency and scalability. This Centre integrates critical functions, including License Management, Regulatory CMC, Regulatory Operations, Labeling, IDMP, Business Intelligence, and Regulatory Data Analytics. Our primary objective is to drive the seamless execution of regulatory deliverables through robust collaboration with Global HQ and other strategic hubs.- Joined… Show more The Regulatory Excellence Centre (REC) is a global hub designed to harmonize and centralize regulatory execution with efficiency and scalability. This Centre integrates critical functions, including License Management, Regulatory CMC, Regulatory Operations, Labeling, IDMP, Business Intelligence, and Regulatory Data Analytics. Our primary objective is to drive the seamless execution of regulatory deliverables through robust collaboration with Global HQ and other strategic hubs.- Joined the community of inquisitive minds, driving curiosity and innovation. - Strategically planned and executed growth initiatives for the Regulatory Healthcare business in India/Bangalore.- Recruited and built a strong, cohesive team of like-minded, highly skilled professionals.- Fully embodied and championed the organization’s core values.- Seamlessly collaborated with global stakeholders to align on key objectives. Show less

Bengaluru Area, India

Program Management for Regulatory Affairs (Generics)- 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

Gurgaon, India

India Leadership Team (ILT) Representative for Regulatory Department- Formulate and implement management decisions within Kinapse India offices- Responsible for smooth functioning of department in Kinapse India- Member of Global Regulatory Affairs Leadership TeamPeople Development Group (PDG) Lead- Work with a group of 10 members for their professional development, training, technical competency - Handle appraisals and effectively communicate tough messages -… Show more India Leadership Team (ILT) Representative for Regulatory Department- Formulate and implement management decisions within Kinapse India offices- Responsible for smooth functioning of department in Kinapse India- Member of Global Regulatory Affairs Leadership TeamPeople Development Group (PDG) Lead- Work with a group of 10 members for their professional development, training, technical competency - Handle appraisals and effectively communicate tough messages - Mentor them effectively for developing future leaders at Kinapse- Ensure happiness and boost morale of the members- Conducting team building activities- Providing a ‘listening ear’ and support for members who have personal or other concerns that are impacting their performance at work- Remote team managementInspection Readiness Group Lead for the Service Line in Kinapse India- Review SOPs, Policies, Green papers, etc. - Help create an awareness of good quality- Worked as audit lead for client audits at both Gurgaon offices as well as in BangaloreProject Lead- Prima facie for client project- Project Management and Administration – Maintain tracker tools, resource management, mitigation of project issues, client discussions, invoicing- Strives for continuous improvement, client satisfaction and deepen client relationshipsAdditional Responsibilities- Business Development work- Recruitment (for India/UK/US)- CSR activities Show less

Gurgaon, India

Management Competencies- People Development Group Lead for 5 members- Project management and administration – Maintain tracker tools, resource management, mitigation of project issues, process improvements, client discussions- Business Development work- Client audits – Quality Lead- Team appraisal- Recruitment Panel memberTechnical Competencies- Working for top 5 global pharmaceutical companies on Regulatory-CMC and Consulting - Preparation of Regulatory… Show more Management Competencies- People Development Group Lead for 5 members- Project management and administration – Maintain tracker tools, resource management, mitigation of project issues, process improvements, client discussions- Business Development work- Client audits – Quality Lead- Team appraisal- Recruitment Panel memberTechnical Competencies- Working for top 5 global pharmaceutical companies on Regulatory-CMC and Consulting - Preparation of Regulatory strategy for site transfers- Authoring and review of CTD Module 1-3 and QOS- Submission of Renewals and Variations in EU and other International markets. Job involves liaising with various client departments and procuring submission ready documents which are then compiled into a data package- Responding to Agency queries- Basic knowledge on Publishing Show less

Gurgaon, India

- Worked with a Top 5 Global Medical Devices Company (Individual Contributor)- Preparation of Regulatory strategy for site transfers- Preparing Cover Letter, Application Form/356h and other Module 1 documentation- Authoring and review of CTD Module 3 sections and QOS- Submission of Renewals and Variations in EU and other International markets. Job involves liaising with various client departments and procuring submission ready documents which are then compiled into a data… Show more - Worked with a Top 5 Global Medical Devices Company (Individual Contributor)- Preparation of Regulatory strategy for site transfers- Preparing Cover Letter, Application Form/356h and other Module 1 documentation- Authoring and review of CTD Module 3 sections and QOS- Submission of Renewals and Variations in EU and other International markets. Job involves liaising with various client departments and procuring submission ready documents which are then compiled into a data package- Responding to Agency queries Show less

Gurgaon, India

- Worked with a Top 5 Global Pharma Company on Regulatory-CMC Project - Lead a small team of 5 members and reported to Kinapse Manager based in UK- Project management and administration – Maintain tracker tools, resource management, mitigation of project issues, process improvements, client discussions- Visited client site in UK for training on Renewals, Variations and client systems

Gurgaon, India

- Worked with a Top 5 Global Pharma Company on Clinical Study Reports, Safety Narratives, Brief Textual Summaries- Worked with a Top 5 Global Pharma Company on Regulatory-CMC Project on Registered Technical Details (RTDs) and variations.

Gurgaon, India

Writing Manuscripts, Abstracts, Posters, Oral presentations, Product monographs etc.

New Delhi Area, India

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

Bangalore, India

- 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- College campus recruitment

Executive General Management Program

Executive Program to further organizational effectiveness and excellence in performance, building upon my experience and enhancing.

M Pharm, Pharmaceutics

Activities and Societies: Debates, Essay writing

B Pharm, Pharmacy

Activities and Societies: Debates, Essay writing, skits, mono-acting

Class Xi - Class Xii, Physics, Chemistry, Biology

Class Ix - Class X, Schooling

Class Iv - Class Viii, Schooling