Regulatory Affairs Manager
AmgenSeoul, South Korea
Posted September 7, 2023
Full Time
About the Company
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Job Description
The Local Regulatory Representative (Manager) is assigned to one or more Amgen products, assisting in aligning local regulatory requirements with Amgen's corporate standards and providing national/regional input to and executing regulatory strategies.
Requirements
- Knowledge of Regulatory principles
- Working with policies, procedures and SOP's
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
- General knowledge of national legislation and regulations relating to medicinal products
- Ability to understand and communicate scientific/clinical information
- Demonstrate strong team work ability
- Good communication skills - both oral and written
- Good negotiation and Influencing skills
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional, country and International borders
