Urmi Das Email & Phone Number

Thane, Mh, In

Mumbai Metropolitan Region

• Managing a group of 90+ people across 5 geographic locations handling 14 different processes that majorly include Global regional planning, Global submission publishing, Report Publishing, Advertising Promotional Review, Planning and submission of Trial Master Files & Aggregate Safety reports and maintaining data in different systems/applications/databases.• Manage timelines, monitoring progress, tracking Key Performance Indicators (KPI), resource allocation and managing budgets. • Conduct thorough project reviews and provide strategic insights and recommendations to enhance project outcomes.• Proactively identify and resolve issues/conflicts by prioritizing actions along with effective and timely decisions• Help in Business unit growth by proactively looking for new areas and working closely with the subject matter experts to put forth new capabilities/services/solutions in front of client in most effective manner.• Coordinates, articulate and develops Change Management Strategy and plans to ensure effective change adoption, successful planning, and delivery.• Establish and maintain strong relationships with key stakeholders, both internal and external.• Frame and facilitate SteerCo meetings effectively with clear decisions/action items between internal and external stakeholders.

Gurugram, Haryana, India

• Lead the department on the regulatory evaluation of external API source(s) during selection/qualification of New Drug Products, In-Licensing Products & Alternate sourcing and to ensure timeliness, accuracy & compliance with regulatory standards. • Coordination with internal & external stakeholders to develop/establish regulatory strategy, project tracking & mitigate any potential risks concerning regulatory submissions. • Collaboration with internal & external stakeholders (vendors) to ensure timely & complete responses to regulatory agency deficiency letters. This involves the review of the response strategy & updated CMC sections.• Conduct people management activities including project planning & execution, interview, selection, training, performance appraisals, goal setting.• Driving Innovate activity at I&DC API for 100+ employees.

Gurgaon, India

• Author & review of new aubmissions, post-approval changes (amendments, variations, annual reports) and query responses for US & Europe market using IBM score & eCTD manager.• Regulatory evaluation of change controls (through Trackwise change management software)• Review of Technology transfer documents (TTD) during the development phase to ascertain fulfilment of regulatory requirements. • Coordination of interdepartmental meetings to discuss regulatory submission strategy, documentation requirements, key issues, deficiency letters etc. to ensure timely approval of the API & Drug Product. • Budget management for regulatory submissions.

Kalyani, West Bengal

• Implementation of IBM SCORE (document management system involving document creation, workflows, document search etc.) & eCTDmanager (dossier publishing tool involving dossier creation, sequence creation, validation, publishing) for regulatory submissions. • Author, review and approval workflows of DMF sections & submissions to different markets within business time frame.

Nasik, Maharashtra

• Compilation of drug product dossier (Module-3) for new registration, annual reports & post-approval changes for submission to US & WHO.• Handing CDSCO licensing activity (Form 25, Form 28, Form 29, Form 46, Export NOC, COPP etc.).• Maintaining the database for all registrations & approvals.

Ambernath, Maharashtra

• Involved in batch release, document issuance and review of documents.

Education record

Pharmaceuticals