Overview

• • Regulatory Management: A process that consists of the purposeful building, developing and managing of long-term relationships with health authorities in the region that has a strategic importance for the Company.
  • The ROLE will oversee all the Regulatory activities for the /Exeltis Portfolio. In particular, he/she will play a lead role, in defining and implementing the regulatory strategy and activities of the current portfolio and understand the key principles of the regulatory processes, & understanding of influence networks.
  • Reporting to the General Manager –the role is an integral part of a dynamic and busy team dealing with multiple clients at any given point and being responsible for advising and guiding senior members of staff on regulatory options and next steps. The post holder must build relationships with internal departments such as commercial, global regulatory and supply chain and with the external regulatory bodies or authority to ensure the highest quality of work is achieved.
  • The role will involve responsibility for Thailand and punctual support for Myanmar and Cambodia.
  • This is a great opportunity for any professional with an entrepreneurial mindset willing to leave his/her footprint, having a big autonomy to lead Exeltis/Chemo products and new.
  • This is a key role in the whole process as it over-arches all other roles; the Regulatory Manager must assess what information is required, coordinate the response material from all parties involved (including sub-contractors and joint partners), and ensure that the completed submission puts forward the best possible response in terms of completeness, appropriateness and that it demonstrates the best added value options to the authorities. The candidate must also make sure that deadlines are met as well as manage appropriately all

Main Responsibilities

• Manage the regulatory process through its entire life cycle.
• Develop and implement regulatory strategy and plan with main focus in Thailand.
• To ensure understanding of the regulatory mapping process, identifying the key stakeholders for each country.
• Co-ordinate, direct and implement the preparation, documentation and submission of MoH (Ministry of Health) applications in requested CTD/eCTD filing format.
• Prepare all necessary translations of documents and ensure that files for submission are complete and made in defined timelines.
• Smoothly manage a response to Request from the authorities across the registration process.
• Produce exceptional quality regulatory submissions, tailored to the requirements of each individual country.
• To cover methodology used to priorities major countries submissions.
• Work closely with all distributors to ensure timely submission of regulatory documents.
• Make personal calls on important customers to build up strong relationship as well as assesses the effectiveness of regulatory strategy and makes suitable recommendations to HQ as necessary.
• To utilize an accurate map and influence network to allocate resources and time within each country.
• Coordinate internally for prompt delivery of regulatory documents to the authorities.
• Maintain contacts with opinion makers, authorities, concerned government officers to promote goodwill and the Company's image.
• Complies with all Commercial code requirements of the Company.
• Give guidance with business and market development, and finding solutions/actions to possible business barriers for registration.
• Responsible for updating all spreadsheets, databases and company records and to produce reports for the higher management when required.
• To develop good working relationships with all company departments.
• An ability to chair and take minutes at internal Meetings as well as ensuring accurate up to date records are kept of all action points.
• To maintain confidentiality at all times.
• Receive and deal with enquiries from colleagues and Clients.
• To develop a SWOT analysis that accurately identifies internal strengths and weaknesses and external opportunities and threats to our business
• Ensure that all internal and external communications on regulatory matters are done flawlessly and in confidential manner
• Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and obedience with regulatory standards.
• Identify fastest way of market access within a compliance and high level of ethical standards
• Prepare and propose together with General Management and related departments of the affiliate and the headquarter best pricing options for submission.
• Continuous follow-up of pricing evaluation of in market product lines and planned molecules/drugs
• Update regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Create or implement regulatory affairs roadmap to make sure that regulatory compliance is sustained or enhanced.
• Maintain database of MoH-approved and marketing approved drugs..
• Responsible of Pharmacovigilance.
• Responsibilities/Cooperation in regards to local manufacturing preparation and/or up-dates of regulatory fillings
• Ability to travel outside Thailand if needed.

Desired Skills and Experience

Desired Skills And Experience

• University Degree (Pharmacy, MD or Science)
• Pharmaceutical background/education with extensive pharma experience in regulatory role.
• Should be fluent in English/Thai.
• Should have through understanding of MoH regulation, pricing and reimbursement and related laws and industry rules governing pharmaceutical products (Drugs, Food Supplements and/or Medical Devices) manufacturing and marketing.
• Should have at least 5 years’ hands on approach in CTD/eCTD filling
• Result oriented and good communicator, excellent verbal and written communication, organizational and managerial skills
• Ability to work in cross functional environment
• Demonstrates and promotes Chemo global value system in all interactions.
• Demonstrates Leadership Behaviors
• Experience of a busy, high pressure working environment is an advantage as the role demands the ability to handle multiple workloads with key task identification and prioritization essential.
• An amount of creativity is needed to produce tailored documents that accurately portray and sell the company’s products and services.
• In terms of location, this role to be based in Bangkok.
• Hands-on and ability to work in a startup environment.
• Business acumen, strategic thinker.
• Very important: the honesty
• Impact and influence
• Adaptable to situations
• Team-working
• Self-Confident