Involved in compliance management for the business, consisting of Biocides and foodprocessing aids.Interacting with business stakeholders on Scientific & Regulatory affairs related projects, programs, issues and communications South East AsiaWorking on documentation necessary for regulatory approvals within agreed timeframes and costs, in order to ensure freedom to operate in the marketInteracting and collaborating with third party manufactures to ensure business continuity under constantly evolving business needs.Monitor regulatory changes, alert business on impacts and handle change management processesHelping DuPont Nutrition & Biosciences RAPS team in advocating required policy changes directly or through other available platforms in the country.

Leading and energizing sales performance with new business development. Influencing clients and high level networking with business leaders from various sectors,such as Pharma, FMCGHarnessing the trade reforms and changing economic policies in India to grow the existing business. Using Excellent leadership skills to achieve tactical and strategic business development and sales. Utilizing market intelligence and analysis to build strategies for YOY growth. International business development with comprehensive knowledge of various markets like India, Bangadesh, Srilanka, Nepal, Kenya,Vietnam,China etc.A statergist and implementer with recognized proficiency in spearheading business with an aim to accomplish greater and greater targets. Represent the Organization to enhance trade relations at various industry and trade assosiations by registering at IPEC, Rx360, ISPE,FSSAI,CII,FICCI and other prestigious industry associationsProviding trainings and consultancy to different businesses by providing techno-commercial inputs.Additional focus in the field of Excipient regulation,impact and requirements.

Life Science Professional with total 15 years of experience.(10 + years as a Research Scientist)My current role as a regulatory management specialist includes providing training and consulting to various stakeholders,viz sales,customers(purchase,QA&QC,regulatory team,formulation development team )government officials etc on regulatory topics for Excipients and API business .I am involved with training the customer support team on enquiry management for regulatory documentation support.I am a member of various non profit industry associations and regulatory agencies working towards improvement and standardization of regulations for excipients in India(like IPEC, Rx360 etc).I am part of a highly proficient regulatory team involved with high level networking ,advocacy,surveillance,policy change influencing for life science businesses like API,Excipients,Medical devices,animal by-products,F&B, biosimiliars etc.I work on procuring NOCs and import licences for API and dual use excipients in India.My past experience as a research scientist (Analytical Chemist,Method development, validation, stability-impurity testing) has helped me immensely in understanding and connecting with multidisciplinary teams both internally as well as on the customer front.I have always been a logical, solution-centric and result oriented person .My strong communication (verbal and non-verbal) along with powerful listening and observation skills help me influence the target audience. Being adaptable to change and making most of what is offered, has been my mantra to professional growth.Having a collaborative approach, curious mind and a can-do attitude has helped me thrive in every role I have taken up.

Resolve technical product queries of customers, determining the cause of the problem; selecting and explaining the best solution to solve the problem; following up to ensure resolution via phone calls, emailInteract with respective stake holders within and across the organization (Global Tech support, Product management, Sales, Marketing, Operations, etc.) in providing effective and timely solution for queries received.Access the company’s internal systems to obtain and extract information and provide customer support.Develop and maintain the business's technical database, provide timely reports, conduct follow up, refer unresolved customer grievances to designated departments for further investigation and increase overall customer satisfaction and retention ,resulting in increase in revenue and brand loyalty.Mainly involved in technical support to Advance Analytics/Lab Essentials division of Merck Milliporewhich encompasses products and services for Inorganics, Organics,Water and Food analysis, Solvents, Microscopy and chemicals for instrumental analysisCo-ordinating with onsite HR, Marketing, Admin and sales Co-ordinator team on day to day basis for smooth functioning of the Tech support group on daily basis. Utilizing the SFDC tool extensively fro data capturing and passing on leads.

Carry out Stability studies related to API and drug products under GLP conditions. Involved with Method development & validation Of HPLC methods for NCEs & NCE Formulations Routine Calibrations of Instruments like HPLC, GC, Balances ,IR, KF under GLP as per scheduleDay to day coordination with Group Leader/HOD to ensure smooth functioning of all activitiesGenerate analytical documents (Analytical method development reports, Stability summary sheets,Validation reports, Calibration reports).Facing Audits and replying to queries. Provide online analytical support during development stage and scale up process,Water testing and environmental monitoring (GMP lab).Analytical method development of API and method validationInvolved in review of data for drug product analysis.Assisting in collection of data of Contract laboratories / cross functional departments Collaborate with people of various teams, groups and disciplines across research centre. Training new recruits / (MSc) college trainees on HPLC, NMR, IR, DSC instruments & applications

Validation and stability study analysis of NCE Drug Products