Career Category

Job Description

Responsibilities:

- Plans, reviews and recommends the best regulatory strategy for submission, including regulatory timeline. Manage and ensures that the regulatory plans are alignment with launch strategies.
- Achieve timely and successful product registrations, including attaining, maintaining and renewing product and operation licenses to ensure in accordance with corporate and local strategies and improve the regulatory position of marketed products.
- Ensure compliance of all systems that impact on the quality of product manufacturing, distribution or storage within Taiwan.
- Build and maintain relationships with key regulatory officials (throughout direct interactions, industry associations, opinion leaders programs) to influence regulations to achieve positive outcomes.
- Keep updating with current local regulations and TFDA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involve or affected parties.
- Create or implement regulatory affairs rules and procedures to make sure that regulatory compliance is sustained or enhanced.
- Effective communication/team working with Marketing, Supply Chain, QA, medical affairs, and other departments/functions to achieve company objectives and avoid supply issues.
- Achieve timely and successful PMF registrations and GMP follow-up renews that ensures facilities, equipment, materials, processes, procedures and products comply with GMP/GDP practices and other applicable regulations.
- Achieve timely and successful DMF registrations, variations and follow-up renews including assessing manufacturing change requests and updating filings accordingly.
- Preparation and submission of the optimized Bridging Study Evaluations (BSE) or designation.
- Cooperate with local safety officer to comply with local regulation requirements. Comply with relevant RMPs according to the defined responsibility.
- Maintain complete filing and storage of all local regulatory & clinical research documents and correspondences to meet local regulation requirements.

- Cooperate with IP lawyers or agent to ensure the compliance of patent linkage related regulations.

Basic Qualifications      

• Bachelor or Master degree with Pharmacist License is preferred.
• Doctorate +1, Masters +2, Bachelors +4 years of directly related experience in drug regulatory affairs and PIC/S GMP related activities
• Knowledge of appropriate regional and country related legislation and regulations relating to pharmaceutical products.
• Should have thorough understanding of regulations governing pharmaceutical products manufacturing and marketing.
• Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance and negotiation skills.
• Knowledge of quality requirements and local GxP requirements
• Pharmaceutical/ Biologics product commercialization and lifecycle management experience
• Native level in Mandarin
• Fluency in English language