Ashok Kumar

Regulatory Project Management for the development products

· Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions for new applications

· Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including Submission delivery strategy of all dossiers and all application types per market and /or region

· Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, regulatory maintenance documents, PSRs, etc.)

· Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product

· Liaise closely with cross-functional members with aligned product responsibilities

· Contribute to process improvement

Associate Director II - Regulatory Business Development (Jun 2021 till May 2022):

Job Responsibilities:

Reg BD Transition lead

· Post-Deal & Pre-Deal Activities: Support the Regulatory BD Lead and TA Reg teams in managing e.g., Regulatory kick-off meetings, population of Data Rooms, Triage of questions (meet 24-hour challenge where possible)

· Provide Customer support: Provide expert advice, guidance and interpretation of matters pertaining to Transition Services Agreements (TSA) to ensure Transfer timelines are accurate and deliverable by the collective team and partners

· Represent AZ Externally: Represent AstraZeneca at external partner meetings

· Drive Collaboration, Provide onboarding and training, Champion a culture of continuous improvement

· Management of deal agreements

Lead Regulatory Project Manager

· Contribute to the GRST regulatory strategy by providing, procedural, documentation, submission planning, and execution expertise

· Prepare and manage the product plan, encompassing all global submissions

· Lead the collaboration between the GRST and GRET and communicates the global strategy and strategic development considerations related to the product plan to the GRET

· Escalates issues/risks for regulatory deliverables identified from the GRET and/or GRET sub-teams, and proposes mitigation strategies

· Lead GRST & GRET sub-teams, i.e., Cross-functional Delivery teams for major activities such as divestments

· Accountable for allocating GRET RPM resources to project-related activities, and clearly outlining GRET member responsibilities, while identifying and leveraging individual RPM expertise to support GRST and GRET activities

Global Labelling Management

This includes:

· the maintenance of core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet, including labeling history documents

· the maintenance and corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs

· ensuring that updates to the core texts are completed, communicated to and implemented by MCs in a timely manner and deviations are agreed and documented appropriately

· ensure that appropriate, up-to-date records are maintained for compliance, including maintaining repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents

· Managing evidence review projects, providing technical direction, and overseeing day-to-day operational aspects of a project and scope

· Create and execute project plans and revise them as appropriate to meet the Client’s requirements

· Key client contact for different projects across varied geographic areas

· Prepare and review deliverables (technical reports and manuscripts) prepared by the team

· Coordinate projects with teams across different locations of the company

· Conduct outcomes research studies applying health economics, patient-reported outcomes, psychometrics, retrospective data analyses, epidemiology, and health services research

· Scientific content development/Medical writing

· Support business development by working on proposals and related budget

Member of Skin & Oral Health CMC team in charge of life-cycle maintenance activities for Oral health products such as denture care creams, powders, tablets, toothpaste, dental kits, etc. Preparing and coordinating for the registration files, annual reviews, CMC documents, variations and renewals files. Managed global regulatory procedures, including responses to Health Authorities’ questions.

Job Responsibilities:

Member of a Regulatory Affairs Franchise team in charge of new registrations and life-cycle maintenance activities (including labeling, variations, and renewals) for sore throat range of products supporting regulatory affairs affiliates worldwide for new registrations and life-cycle maintenance of sore throat range of products. Preparing and coordinating the registration files, labeling documents, CMC documents, variations, and renewals files. Managing global regulatory procedures, including responses to Health Authorities’ questions.

· Providing regulatory advice regarding new opportunity evaluations (including due diligence), registrations and life-cycle maintenance, with the support of the Franchise Program Lead. Represents GRA in Project Teams for assigned projects.

· Responsible for all regulatory labeling matters related to regulatory activities for the assigned product portfolio, across the countries. Created, maintained, and ensured the delivery of regulatory compliant, competitive, and up-to-date global labeling documents for defined product portfolio.

· Acting as a subject-matter expert (SME) within the GRA Franchise teams in a specific area of expertise. Contributed to special assigned projects or activities by providing regulatory expertise, where applicable, and represented GRA in cross-functional projects or assignments.

· Leading and coordinating globally for life cycle management of marketing authorization license of pharmaceutical products i.e. renewals, variations, GMP recognition, APQRs etc.

Global labeling Manager (Jan 2011 to Mar 2014):

Job Responsibilities:

Led, managed, and supported Global Regulatory Affairs (GRA) Global Labeling (GL) category activities, acted as a single point of contact for all GL related activities, liaised with Research and Development (R&D) Global Line Functions (GLF), regional or country Regulatory Affairs (RA) organizations in the development and execution of global Product Information (PI) strategies and documents for the product portfolio and projects within each category.

· Responsible for all regulatory labeling matters related to regulatory activities for the assigned product portfolios, across the countries. Created, maintained, and ensured the delivery of regulatory compliant, competitive and up-to-date global labeling documents for defined categories.

· Executed the development of Core Product Information (cPI) documents: Core Safety Information (CSI), Core Data Sheet (CDS), Core Patient Information Leaflet (cPIL), regional Summary of Product Characteristics (rSmPC); US product information (US PI) and their implementation to the local/national PIs.

· Present proposed changes in global product information documents to the GLC for review and approval.

· To apply project management skills throughout the entire process, from the decision to update a CDS/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.

· Management of labeling issues: led cross-functional Expert Teams in the strategic management of labeling-related crisis situations with Health Authorities (HA).

· Periodic Safety Update Report (PSUR): Provided high-quality and timely global regulatory input to PSURs for assigned product categories and follow up on potential cPI commitments in PSURs.

th rank in NIPER Entrance exam 2005, 9.12 on, 4th Semester, GATE

• Thesis: [Name of Thesis]Effect of Calorie restriction on progression of Diabetic Neuropathy
• Major in [Subject] Pharmacology & Toxicology
• [Number] GPA 9.12

GPA: 71.77%

GPA: 80.0%

GPA: 72%