About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit
www.beonemedicines.com
and follow us on LinkedIn
and X
(formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
The Manager or Senior Manager, Regulatory Affairs will be responsible for managing investigational new drug application (IND) related regulatory works and drug registration process in timely and efficiently from beginning to end in accordance with regulatory requirements and coordinate regulatory activities between cross-functional teams.
Key responsibilities and role:
- Prepare, submit and support clinical trial applications and product registration.
- Obtain successful regulatory submission and approval of new products and be compliant and effective with all product safety activities in Korea
- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy with compliance with the relevant law and internal procedures.
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
- Maintain up-to-date knowledge of relevant regulations, including proposed and final regulations and provides regulatory affairs related information to other divisions and department
- Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
- Develop and maintain standard operating procedures or local working practices.
- Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
- Ensure registered products and clinical trials are maintained and updated in full compliance with all relevant legislation and SOPs, etc.
- Assist Regulatory Country Head in managing activities such as audits, regulatory agency inspections, or product recalls, etc.
- Assist Regulatory Country Head in coordinating regulatory activities across divisions.
- Manage and oversee the direct reports
Qualification Required:
Education Required:
B.S. in Pharmacy or Life Sciences
Other Qualifications:
- Minimum 7 years of work experiences in regulatory affairs and Minimum 9 years of experiences in pharmaceutical Industry in Korea
- Strong knowledge of current Korea regulations
- Computer Skills: Experience in working with MS office in a Windows environment
- Negotiating, communication and interpersonal skills
- Fluency in written and spoken English
- Experiences of people management (preferred)
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (
https://beonemedicines.com/privacy-policy
).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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