Senior Manager, Regulatory Affairs, Vietnam - BeiGene

Mô tả

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  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:

About the Position

The Senior Manager, Regulatory Affairs, Vietnam is responsible for ensuring the regulatory compliance of therapeutic products in Vietnam, by developing regulatory strategic plans in conjunction with project teams, by setting the strategy for submission of product registration documents, and by filing CTA & MAA submissions (including variations).

This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and lifecycle of the product. This person will serve as the Chief Representative of BeiGene's Representative Office in Hanoi city and will be responsible for managing and overseeing all operations of the Representative Office in accordance with applicable laws and within the authority granted by the foreign parent company.

Essential Functions of the job:

Main Responsibilities

• Be the licensed pharmacist and licensed holder for the local Representative Office in Vietnam.
• Obtain successful registration of new products and be compliant and effective with all product safety activities.
• Manage and oversee all relevant maintenance activities potentially including Lifecycle Management strategy.
• Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
• Provide expert regulatory input to strategic decision making, including portfolio review, prioritization, and external communications.
• Participate in global regulatory meetings representing Vietnam. Global meetings may be outside of Vietnam office hours.
• Prepare, submit and support clinical trial applications.
• Establish regulatory priorities or budgets and allocate resources and workloads.
• 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.
• Maintain current knowledge of relevant regulations, including proposed and final regulations.
• Support for new products launch.
• Provide Support with Health Authority and Business Partner audits.
• Responsible for checking all business-related letters sent to Vietnam office and support administrative work when required.

Supervisory Responsibilities:

• Supervision of Regulatory Affairs Associates/Regulatory Affairs Managers as required in future.

Chief Representative Responsibilities :

• Responsible for all activities of the Representative Office and must act within the authority granted by the foreign parent company.
• Must ensure the Representative Office operates within Vietnamese legal frameworks, including labor, tax and reporting regulations.
• Responsible for submitting annual reports and other documents as required by regulatory authorities.

Qualification Required:

Education Required:

• Bachelor of degree in Pharmacy.
• Registered pharmacist in Vietnam.

Qualification:

• Expert on the Vietnam drug regulatory legislations and requirements
• A minimum of 6 years in the biotechnology or pharmaceutical industry and a minimum 6 years in Vietnam Regulatory Affairs.
• Registered pharmacist in Vietnam.
• Regulatory experience in other SEA countries will be added advantage
• Experience in Oncology, specialty care medicines preferred
• Strong collaborator who can incorporate input from others and can generate consensus through inclusion
• Highly skilled in influencing cross-functional teams, including interfacing with key internal and external stakeholders and with scientific and commercial teams
• Excellent interpersonal, oral and written communication skills
• Fluent English, oral and written
• Proven ability to grow and develop others
• Demonstrated experience in challenging the status quo
• Strong can-do attitude and flexible mindset
• Mature and independent professional, making sound judgements
• Attention to details, organized and results-oriented

Computer Skills: Proficiency with MS Office, Data Management Tools, Adobe Acrobat, Sharepoint, Zoom, MS Team are required

Travel: as required

Work Location: Hanoi office

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Long Term Incentive Plan
• In-house and external learning and development opportunities
• Comprehensive benefits program
• 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

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