Amit Kumar Das Email & Phone Number

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.

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.

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.

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.

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.

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.

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.

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.

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