Chitralada Submanee Email & Phone Number

Thailand

Thailand

- Obtain fast new drug approvals, variation and renewals of already approved drugs tgrough preparation of the required documentation and through follow-up with local health authorities- Proactively identify regulatory trends and communicate potential impacts on company business to ensure understanding for the regulatory mapping process, identifying key stakeholders for Thailand- Develop and implement regulatory strategy and plan with main focus in Thailand- Co-ordinate, direct and implement the preparation, documentation and submission to Thai FDA applications in requested CTS/eCTD filing format- Process and report to GPV and Health Authorities all safety information received from market, post-authorization studies, scientific literature and Health Authorities in accordance with national legislation and internal procedures- Manage the product quality complaint process and handle product recalls, including conducting relevant training to all employees and local agent(s) on safety reporting, complaint management and product recall- Dispose finished product for distribution or delegate the task to appropriate trained individuals- Provide QA oversight of local quality systems and activities perform by distributor- Review and approval of promotional material according to local legislation, codes of practice and internal SOPs- Act as the Document Responsible Person (DRP) for distributing and filing internal SOPs- Manage all process for license per invoice and related documentation to release all shipment from customs**Achievement / Success Stories**- Get product approved from Thai FDA for Favipiravir (Avigan) within 2 months’ time.

Thailand

- Developing Brand Strategy and positioning in current market- Implement and execute business plans and marketing strategies to direct company's objectives- Proactive discuss with selected hospital tender committee and KOLs on specification before official announcement to extend listing status- Work closely with Government sectors (NHSO, SSO, GPO, CGD and all related stakeholders) to ensure our products are eligible for National Tender submission, include work close to field force for each hospital enlisting and tender- Analyze the Tender opportunity and find out the solutions and opportunities to improve sales performance, provide information on customers and competitors for Sales and Marketing Team- Tender Tracking, monitoring the results and consolidate report for management decision- Expert on technical product specification and support documents to ensure all specification and support documents are updated for tender- Coordinate with related functions to prepare dossier for tender/ hospital enlisting and update the annual price database of each hospital- Establishing strong and sustainable relationship with key stakeholders- In depth knowledge of customers, competitor activity, market share, key decision maker and overall situation in the market- Sales and marketing strategies development with Global marketing team from HQ in Korea and coordinate with local distributor- Act as Medical Affairs to deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.), where requested- Prepare all related document for customs clearance and logistic process to prevent any issues on detention or custody of shipment**Achievement / Success Stories**- Appeal against NHSO tender for Trastuzumab and Rituximab market to revise specification and open for biosimilar to competition in NHSO/SSO tender- Make company become winner in NHSO/SSO tender for Trastuzumab and Rituximab

Thailand

- Work cross functionally and closely with global and local stakeholders to develop integrated regulatory strategy to align to patient needs and commercial objectives- Ensure that all applicable licenses are available, comply with local regulations and renewed accordingly- Pre-registration activities such as review of regulatory requirements, agency communication and discussion to ensure timely submission- Registration submission and follow up till approval in a timely manner with business time line- Implement and monitor legal activities relating to product registration and promotional materials for all products launched in Thailand- Ensure Regulatory Intelligence, policy update are collected, assess and notify global and local when applicable- Develop, maintain good relationship with Government Authorities, and keep company update about governmental rules and regulations that will impact on company business- Serve as the primary point of contact with the Thai FDA. Assemble and lead teams to develop response strategy to address Thai FDA submission responses, inquiries and information requests- Manage registration and legal activities of the regulatory affairs department in term of product registration, product life cycle management, clinical, medical, quality assurance and pharmacovigilance activities and/or company responsible pharmacist when applicable in compliance with Company Operating Procedures (SOPs), regulatory affairs procedures and local agency regulations- Contribute to promote the regulatory affairs image of the company and to establish and develop the professional relations with the key experts / leaders in Thailand, especially in Biological / Biosimilar products**Achievement / Success Stories**- Get approved from Thai FDA for Infliximab biosimilar as 1st Monoclonal Antibodies biosimilar in Thailand.- Get approved from Thai FDA for Trastuzumab and Rituximab biosimilar.- Be as pioneer for Thai FDA to do GMP clearance as PICs manufacturer.

Thailand

- Sales and marketing strategies development with Global marketing team from HQ in Korea and coordinate with local distributor- Sales strategy development and planning for pre – launch, and launching campaign together with promotional activities and patient assessment program- Distributor management, share and update information related on regulatory affair and marketing with distributor as monthly basis- Training product knowledge, clinical study data and medical data to sales team- Consolidation of marketing performance and sales activity results- Simulate sales forecast, budget and product supply- Network development with KOLs networking and prospect new customer accounts & relationship maintenance- Coordinate with Thai FDA for regulatory compliance and support Regulatory affair team in the regulatory related activities as assigned- Establish and maintain all relationship with related person in Thai FDA and other government organizations- Manage all process for license per invoice to release all shipment from customs- Coordinate on adverse event reporting / pharmacovigilance activities- Develop and design protocol for post marketing surveillance study and cooperate with clinical team from HQ to finalize protocol- Prepare and organized for investigator meeting, manage all study centers during running study and data collection- Represent Celltrion Healthcare & Celltrion Inc. by engage and participate with government sectors (which is FDA, CGD, NSHO and SSO office for future strategies.) and business partners to achieve the desired business goals- Contact with all related government authorities for business set up (e.g. Department of Business Development- Ministry of Commerce, Revenue Office)- Other special assignments from company to assist with global regulatory affair team in product registration processes

Bangkok, Thailand

• Area responsibilities (Bangkok area; Ramathibodhi Hospital, Rajavithi Hospital and Up-country; Northeastern, Western and Southern area)• Handle sales target, achieve sales objectives and promote product which complied with compliance.• Promote the company’s sales growth by promoting responsible products• Maintains and Demonstrates scientific knowledge with concerned person (Rheumatologist, Dermatologist, GI man, Interventionist, Cath Lab nurses, Infusion nurses and Pharmacists)• Build up and maintain long–termed relationship with key customers, opinion leader and influencers for responsible product field.• Develop territory sales strategies to ensure that sales target• Ensure implementation of all marketing activities and promotion programs• Assist Business Unit Manager, Product Manager to develop, manage and control all sales, group meeting and others activities in responsible area and products

Bangkok, Thailand

• Area responsibilities (North, North – eastern and Central regions)• Supervise, monitor and evaluate a team of sales force of assigned products and activities for responsible areas and territories in order to achieve the agreed sales target• Information services for sales representatives, nurses, physicians and other customers• Professionally and ethically conduct the sales activities as required the Corporate Principles, Behavior in Competition, Local Authorities• Support Sales Team for group customer’s activities.• Responsible primarily to surpass the marketing for the assigned product line by effective planning, management action and motivation• Set and prepare documentation for group in service program to customers. • Visited market, exchanged and get some information from customers (both physicians, nurses and pharmacists)• Other duties as assigned by superior

Bangkok, Thailand

• Product focus : IVIG, G-CSF, Blood Product• Prepares product marketing plans and marketing strategies for assigned products• Prepare print items which reflects product strategies and objectives under all imposed guidelines• Created new up date literatures, gimmick• Plan, monitor and control the budget in relation to product promotion plan activities, new launch plan, and other related issues under review off the Business Unit Director• Search new information about products, competitors and trend of market.• Information services for sales representatives, pharmacists, physicians and other customers• Set training schedule and products knowledge to sales representatives• Set and prepare documentation for tender and enlist• Visited market, exchanged and get some information from customers (both physicians and pharmacists)