Manager/Senior Manager, Regulatory Affairs, Malaysia

Manager/Senior Manager, Regulatory Affairs, Malaysia page is loaded Manager/Senior Manager, Regulatory Affairs, Malaysia Apply locations Malaysia time type Full time posted on Posted 3 Days Ago job requisition id R22933

BeiGene 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 BeiGene:

BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of over 10,000 colleagues across five continents.

About the Position:

The Manager/Senior Manager, Regulatory Affairs, Malaysia is responsible for ensuring the regulatory compliance of therapeutic and investigational products in Malaysia, 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). Ensure compliant and uninterrupted supply of BeiGene products or the import products from collaboration partners in accordance with BeiGene’s quality management system and Malaysia regulatory authority expectations

Main Responsibilities

• Be a licensed pharmacist and Poison License A holder (backup) for the local affiliate in Malaysia
• Prepare, submit and support clinical trial applications.
• 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 regulatory input to strategic decision making including portfolio review, prioritization, and external communications.
• Maintain current knowledge of relevant regulations, including proposed and final regulations.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Ensure local activities comply relevant GDPs and Quality Management System including warehouse, distribution and Lab management, support relevant GDP activities in Malaysia.
• In country disposition / release activities for Malaysia.
• Support external inspections, complaints, deviations, recalls, counterfeits and product tampering according to the BeiGene quality system procedures
• Participate / respond to corporate audits and self-assessments for responsible countries
• Management of temperature sensitive products including lane qualifications, shipper qualification, temperature excursion assessments, transport validation
• Support for new products launch.
• Support with Health Authority and Business Partner audits

Qualification Required:

• Expert on the Malaysia regulatory legislations and requirements
• A minimum of 5 years of regulatory affairs experience in the pharmaceutical industry
• Experience in CTIL/CTX highly preferred
• Experience in oversight the drug wholesaler and distributors
• 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

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, diverse and fun professionals whose mission is clear: Cancer has no borders and neither do we.

BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

BeiGene 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

BeiGene 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 BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant 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) BeiGene’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) BeiGene’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.

About Us

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

At BeiGene, how we work is just as important as the work we do . Below are our Values that determine the decisions we make and how we do things. #J-18808-Ljbffr

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