Career Category RegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring brand-new medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in groundbreaking manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) are the fastest growing region in Amgen. Now we are hiring a Regulatory Affairs Associate Manager in Taipei.LiveWhat you will doWe are looking for a Regulatory Affairs Associate Manager (RA) who will be instrumental in devising the regulatory submission strategy, coordinating with cross-functional teams, executing tactics, and managing RA-related systems. This pivotal role will be under the direct supervision of the Head of RA. The selected candidate will collaborate closely with the global team and cross-functional colleagues to verify local requirements and submission dossiers, offer regulatory insights, and identify and address potential risks. The RA team will depend on your specialized knowledge and adaptability to ensure the successful implementation and realization of plans.Key Accountabilities:Take ownership of the RA strategy and its execution.Collaborate effectively with cross-functional teams to meticulously implement each variation/update.Adhere to local regulations and internal Standard Operating Procedures (SOPs).Demonstrate excellent communication, organizational, and time management skills to ensure timely submission of documentation.Main Responsibilities:Collaborate with Clinical Operation team to plan and execute clinical trials in Taiwan.Recommend and develop the best regulatory strategy, align cross-functional teams on submission timeline and priorities. Compile and manage regulatory submissions and communications with health authorities in Taiwan, including drug registrations, pre-MAA activities, product license renewals and life cycle management.Drug Master File (DMF) registration and renewals.Bridging Study Evaluation (BSE) reports preparation and submissions.Post-approval CMC variations and/or labeling updates.Product license renewals.Achieve timely and successful Plant Master File (PMF) registrations, periodic PMF renewals and relevant post-approval changes to maintain compliance with PIC/S GMP, GDP and other applicable regulations.Ensure high quality submissions that comply with local regulations and registration requirements. Make sure archival of submission documentation in compliance with internal SOPs.Provide regulatory affairs support to cross-functional team, including Risk Management Plan (RMP) or Perodic Safety Update Report (PSUR) preparation, drug supply management, reimbursement application, or commercial activities.Support Head of Regulatory Affairs with policy shaping and interaction with key regulatory stakeholders through direct interactions or participation in industry associations.Provide Regulatory Intelligence and keep key stakeholders informed of local regulation changes or potential changes that could impact business environment.Handle other projects or tasks assigned.WinWhat we expect of youBasic QualificationsBachelor’s or master’s degree in Pharmacy, Life Sciences or related fields.Qualified pharmacist preferred.Minimum three years of relevant experience in pharmaceutical industry with good understanding of local regulations and requirements.Demonstrate the ability to communicate clearly and efficiently in both written and verbal English and Mandarin Chinese.Exhibit a strong sense of responsibility with the ability to work independently and possess an analytical and problem-solving mindset.Possess good organizational and time management skills with attention to detail.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organization.Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.Generous Total Rewards Plan comprising health, finance and wealth, work/life integration, and career opportunitiesApply nowfor a career that defies imaginationIn our quest to serve patients primarily, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..
