Pranab Gogoi Email and Phone Number

Thought Leadership through various strategic engagement for business growth.Leading Regulatory Labeling & Artwork Operations COE - Practice; Vision; Strategy; Business Growth; Solutioning; Operations. Creating Bespoke solutions for Pharma, Medical device and consumer clients. Practice Head and Strategist on Regulatory Labeling Ecosystem from Global Labeling Management to Regional Labeling and compliance to Artwork Management. Consulting expert in Packaging Artwork Supply Chain requirements. Bespoke Labeling Artwork LCM Technology Solutioning for Customers.Experienced in diverse Labeling Artwork process flows and related technology roadmap of various Lifescience company that are propelling their day to day activities. In addition, assisting Growth and Strategy for Medical & Scientific Communication (MSC COE) Practice at Freyr. Driving excellence in delivering comprehensive scientific communication services. My role integrates Business Development combined with Go-To-Markets strategies, Designing marketing roadmap and implementation, Creating Solutioning documents, operational oversight and blending strategic thinking with creativity.Managed Regulatory Programs (Strategic Clients) As a Program Manager, I collaborate with multiple clients to meet diverse regulatory needs, overseeing 150+ associates. Contributing to governance meetings, making strategic decisions and ensuring their implementation. Responsibilities include addressing technology and manpower requirements, recruiting top talent, reporting engagement financials and maintaining accurate project data for informed decision-making.

@ Wipro Life Sciences Vertical Regulatory Affairs - Strategy, Practice, Solution, Business Development @ Pharmaceuticals | Medical Devices | Cosmetics | Food & Food SupplementsAnd bespoke technology solutionsDeveloped and executed strategies on service deliveries for various functions, starting from product launch strategy, regulatory landscape and post authorization compliance.Catered to a renowned global Lifesciences company as Regulatory Affairs Program Manager with governance and niche resource management. Provided solution under CMC, Submissions, RIMS, IDMP/DADI.Forging strategic partnership with various Service and Technology providers.Onboarding of strategic human capital for niche lifescience delivery.Providing inputs for organic as well as inorganic growth strategies. Showcasing prospective clients with regulatory strengths & capabilities.

At Athreva, I ensured perfect delivery of projects with a focus on quality, customer relationships, and effective internal operations according to prepared plans and controls. My responsibilities included providing regulatory and compliance solutions for pharmaceuticals, medical devices, and cosmetics projects. Key Contributions:> Prepared and executed ISO audits, both internal and external, with certification from BSI.> Managed key quality indicators for each project and cross-functional departments across various industries.> Oversaw project financials, including projections and cost structures, ensuring adherence to defined delivery standards.> Created Service Level Agreements (SLAs) with customers for industry-specific projects.> Drove business development by connecting with prospective customers and creating proposals and solutions for delivery.> Handled customer delivery issues and escalations, proposing alternative solutions when necessary.> Regularly communicated goals, KRAs, career objectives and policies to resources and internal stakeholders.> Conducted data analytics for the life sciences industry.> Managed Athreva team and consulting resources, ensuring their performance, motivation and development.> Controlled internal audits to periodically check compliance.> Collaborated with HR for personnel management, ensuring the right candidates with the right mindset were hired.> Established artwork supply chain processes for a European pharmaceutical company in a consulting role.> Provided solutions related to regulatory artwork technologies and processes.

• Global Labeling & Artwork Department• Global Delivery to Novartis Supply chain units related to Packaging Artwork development. • Labeling & artwork operations for Pre-approval and post approval drug products. • Managed Packaging Artwork Excellence center for Novartis Project & handled processes related to each manufacturing site as one of the vendors. • Multi-site operational- Artwork lifecycle Management function.• Managing and supporting design and quality team on creation and revision of packaging components within the agreed process. • Operations per Standard Operating Procedures (SOPs). • Client’s primary point of contact for all Artwork supply chain, operations, delivery, quality, vendor registration & invoicing with different global Novartis sites and managed all communication with client’s Supply Chain department. • Attended Annual Vendor Meeting Global Artwork Team at Global sites. • Transitioned functional processes from various global manufacturing sites. • Meetings with Global process team on process improvement and quality standards • Data analysis -Weekly and Monthly reports along with delivery details with quality measures. Reporting was as per the KPIs defined. • Responsible for supplying internal management with monthly P&L related to operations, which included manpower, instruments, hardware, software, subscriptions, etc. for engagement.• Well versed with technical requirements related to the project, related tools and their usage that helped in implementing the project perfectly.• Quality Management - Handling issues and escalations related to artwork pack management from internal and external customers by identifying the root causes and suggesting the CAPAs.• Manage internal Audits to check the compliance on a periodic basis.• Reporting on the monthly revenues and cost structure.

• Global delivery with FTE Model engagement. • Global Labeling and Packaging Artwork Excellence Center created for Apotex. • Labeling and artwork operations for Pre-approval and post approval products. • New Artwork Process creation as per New Technology implementation. • Transitioning stakeholders on new process and technology requirement. • Reporting on monthly revenues and cost structure. Revenue predictions month on month as per the invoicing and contract. • Reporting on cost structure related to the delivery team. • Managed lifecycle managers, Artist as well as Quality Analysts. • Engagement with customer with setting up of Operations and Supply Chain meetings. • Managing & ensuring new pack artwork creation and pack artwork changes are produced in accordance with service level agreements.• Managing and supporting graphic design team for creation and revision of packaging components within the agreed process with the client.• Handling issues and escalations related to pack management from internal and external customers by identifying the root causes and suggesting the CAPAs.• Personnel Management - Communicating the resources & stakeholders on goal sheet, KRA, career objectives and policies on regular basis. Responsible for the performance, motivation and development of all staff and teams in the Business Unit. • Manage internal Audits and external audits - Quality and Compliance

• Responsible for the designing of covers and pages of the group magazines, namely Blouin Art+Auction, Blouin Modern Painters and Blouin Lifestyle• Coordinating with publishers and editors on the roadmap and all the necessary design corrections on pages.• Multitasking and working under strict deadlines as and when required. • Coordinating with Photo Editors/Publishing coordinator for the images of AA and MP. • Responsible and ensuring all pages are done as per standard procedures till pre-press. • Designing for Social media pages.

• Joined the pilot team of MINT, a business newspaper, in 2007 in collaboration with Wall Street Journal. • Managed a team with various functions within Art department, i.e., Photographers, Infographic Designers, Illustrators and Layout Designers.• Managing design of MINT newspaper, Mint Asia and Saturday’s magazine named Lounge. Also involved in UI Designs of products related to digital version of newspaper.• Responsible for the overall quality of design output and its contribution to project objectives.• Coordinating photo-shoots for the newspaper. • Causal Photography for newspaper. • Coordinating with Editorial team and the Pre-press on everyday publishing of the daily newspaper.

#GSK• Part of Pilot team to manage Pharmaceutical Labelling artwork lifecycle management - Regional Service Centre, India, managed by Tech Mahindra (Formerly Satyam Computers).• Involved in Transformational journey of Artwork lifecycle management. Supply Chain process, Transition Management, Technology, Cost effective Operations, Driving Process Improvements, and Customer Relationship Management of the GSK process.• Managed team of 80 resource, directly and indirectly.• Resource management including recruitment, training, appraisals. • Training new entrants with the best practices so as to have minimal deviations.• Managing team operations along with labelling artwork production. • Ensuring productivity levels are maintained on the parameters of quality as well as quantity.• Delegation of work, maintenance & development of worksheets and client interactions.• Following SOPs and System Instruction documents for all process related requirement and execution of pharma packaging artworks. • Preparing of Local Standard Operating Procedures and Process Maps.• Tracking of customer issues and ensuring resolutions as per standard procedure. • Annual job evaluation of employees and assessing their performance time-to-time.• Traveling to Global GSK sites for transition management and for new process transformation. • Had good command over the processes and workflow execution. • Awarded by GSK on Excellence for contribution to the process.