Amgen Regulatory Affairs Associate Manager (CW) in Taipei, Taiwan
Collaborate with Clinical Operations team to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements.
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.