This is a cluster role which the candidates need to manage product registrations to comply with local regulations and also corporate guiding principles. Develops appropriate submissions to register drugs to government officials.

This position will also implement and manage the Affiliate Quality standards ensuring adherence to corporate and local procedures. Develops and implements strategies and tactics to expedite registrations, contributing to the earliest possible introduction of products and attainment of company’s profit objectives.

Main Responsibilities:

Product Registrations

• Participate in the local strategic planning to establish objectives of registration of new products according to Corporate Regulatory Affairs’ policy and the local affiliate’s objectives.
• Develop, coordinate, file and monitor submissions of new products according to priorities.
• Elaborate submissions of Ipsen products based on business strategies and in compliance with local regulations.
• Develop and implement strategies and tactics to expedite registrations.
• Develop and maintain a good relationship with government officials at the Ministry of Health.
• Meet health officials to work on priorities.
• Renew product registrations and company’s licenses in the due time.
• Elaborate submissions of new and me-too products, as well as renewals, modifications of formula, new pharmaceutical forms and strengths and other amendments (p H change, expiration date extension, new packaging, new labelling text, new trade sizes, change of name, etc.) according to regulations.  Develop and implement registration strategies
• Develop regulatory responses, appeals, justifications, supplements and any other applications and comply with any requirements from the Ministry of Health.
• Develop registration data for locally developed or acquired products.
• Follow legislation through official gazette and, if applicable, issue orientation to the departments involved for Implementation.
• Revise finished artwork of packaging material according to legal requirements and manage any alterations with departments involved.
• Review promotional material for regulatory compliance.
• Develop, coordinate and provide technical and legal documentation as required/requested by the importing markets of ex-Taiwan products.
• Submit and obtain approval of clinical trial protocols of R&D and local projects.
• Set up local inspections/joint inspections with Taiwan health authorities for Good Manufacturing Practices certification.

Ensure QA standards adhere to Corporate and local procedures

• Develop and implement local “standard operating procedures” (SOPs) in accordance with current laws, corporate standards/policies and business needs. Further maintain SOP process regarding periodical reviews etc.
• Assure training of all relevant people regarding effective quality standards e.g. SOPs, Corporate standards etc.
• Implement and manage the Change Control activities within the Affiliate and the interface with other processes e.g. CMC change control, etc
• Assure compliance to corporate quality standards e.g. Delivery of cold chain products
• Assure customer complaints including vigilance are reporting accurately to headquarters.
• Assist crises management teams in a case of recall.
• Assure audit activities in collaboration with the audit team and supporting departments in terms of audit preparation.
• Assure reporting deviations e.g. Temperature excursions of temperature control products including cold chain products
• Assure monthly status report to relevant parties.
• Assist in annual product quality reviews.
• Manage third party redressing/repacking activities and the release to market.

Compliance and Governance

• Observe compliance of specifications of products to those the registration in all standard operation procedures.
• Regulatory support for the development or acquisition of new products.
• Coordinate New Products Committee meetings.
• Represent the company at the Ministry of Health.
• Participate in meetings at associations of class on regulatory issues.
• Make contacts with accredited certification organism for certification of conformity of equipment.
• Represent the company at competent departments against unfair competition of product advertisement.
• Identify business opportunities and contribute with action under regulatory responsibility for the global result of the company.
• Assume special projects or duties as assigned by management.
• Responsible for regulatory intelligence collection and management.

Knowledge, Abilities & Experience:
Education / Certifications:

• Minimum: Bachelor degree in Pharmaceutical Sciences and related
• Preferred: Master degree in Pharmaceutical Sciences and Laws.

Experience:

• Minimum: 5-10 years of experience in Regulatory Affairs and Quality Assurance.
• Preferred: 10-15 years experience in Regulatory Affairs and Quality Assurance.

Languages:

• Professional level in English in all aspect

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