面議(經常性薪資達4萬元或以上) 台北市信義區 2年工作經驗 1天前更新
JOB DESCRIPTION
POSITION SUMMARY
(Key Responsibilities of the Position)
• Support product license maintenance, variations, and renewals, ensuring regulatory submissions are completed within required timelines.
• Prepare regulatory documentation, consolidate submission packages, and coordinate filings with regulatory authorities to maintain compliance and operational efficiency.
• Collaborate with cross-functional teams to support product registrations, lifecycle management, and other regulatory projects.
• Maintain regulatory documentation and databases, ensuring timely and accurate regulatory information is available to internal stakeholders.
• Support ongoing regulatory compliance throughout the product lifecycle and contribute to business continuity.
WORKING RELATIONSHIPS
• Report to the Head of RA, Taiwan.
• Represent the RA role & objectives to both internal & external partners to promote mutual trust and collaborations.
• Cooperate with relevant stakeholders to share information & provide a good understanding on RA-related issues.
EDUCATION AND EXPERIENCE
• Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or related life sciences.
• Master’s degree may be an advantage.
• Minimum 1-2 years’ Regulatory experience.
TECHNICAL SKILLS REQUIREMENTS
• Excellent speaking, reading and writing capability in English & Mandarin.
• Proven ability to manage complex and time-critical regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Local regulatory experience including knowledge of NDA/ANDA submission processes and product life cycle management activities.
• Strong communication skills.
• Strategic thinking and business orientation to ensure the regulatory plans meet business goals.
• Proven ability to manage complex and time-critical regulatory issues.
• Ability for decision making.
• Relationship management, collaboration and influencing skills.
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