Associate Director/Senior Manager, Regulatory Affairs, Singapore and South East Asia
1 month ago
Job Description:
About the Company:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across the United States, China, Europe and Asia Pacific region, 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.
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.
About the Position
The Associate Director, Regulatory Affairs, SEA will be responsible for developing, implementing, and advising on SEA regulatory strategies for development programs to secure and maintain market access for product(s) in SEA region in line with business objectives, and in coordination with key internal stakeholders.
This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and lifecycle of the product.
This role will directly manage a team of regulatory affairs professionals across a range of levels and
assets and must be equally adept at providing technical as well as professional growth and leadership to the team.
The position could be in major SEA countries Beigene has presence.
Essential Functions of the job:
Build and lead the Singapore and SEA regulatory team across various locations in the region. Supervise team members and external vendors to the Regulatory Affairs function and provide management and guidance across the function. Manage the Singapore and SEA regulatory team activities, budget and staff including identifying, hiring and training additional staff as needed. Work in close collaboration with BeiGene Global functions to integrate all aspects of SEA regulatory strategy. Drive Regional Regulatory Affairs strategy and execution for the organization across key focus areas in hematology and solid tumours. Represent Regulatory Affairs in the SEA Leadership team. Ensure interactions between Regulatory and other functions in the SEA region are managed optimally. Work in close collaboration with SEA functional heads to integrate regulatory within clinical development, commercial, medical and market access etc initiatives and strategies. Oversees regulatory aspects of submissions and communications with the respective Health Agencies by departmental staff. Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained up to date. Oversees strategic placements of key SEA countries in global clinical development plans. Provide strategic regulatory support to internal brand, product and project teams. Proactively communicate the latest regulations, guidance, and actions from SEA countries and competitors that may influence the landscape and assesses the potential impact on regulatory and/or business strategy and planning. Contributes to the development and implementation of processes and procedures relevant to the operations of the regulatory function and its interactions with internal stakeholders. Oversee all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory agency applications, safety, amendments, and IND safety and annual reports. Represents BeiGene in industry associations relevant to the Asia Pacific region.Qualification Required:
Qualification
A minimum of 8 years in the biotechnology or pharmaceutical industry and a minimum 6 years in Singapore Regulatory Affairs with a broad background in oncology. Knowledge of Inflammation and Immunology a plus. Preferred candidates will have experience working as a lead in Regulatory Affairs across 2-3 SEA countries, prior experience with both small molecules and biologics Experience leading multiple HA interactions leading to Agency approval actions. Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.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)
Full-time working from home (with an option to work from the Sydney office)
In-house and external learning and development opportunities
Fantastic benefits program as per the current policy including;
Personal health insurance reimbursement
Home-office setup allowance
Monthly reimbursement for home office expenses (i.e. internet, mobile..)
Group life insurance & income protection insurance
Wellness benefits (Employee Assistance Program)
Paid parental leave
And more as the benefit programs are 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:
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