Senior Regulatory Affairs Associate

Job Description:
About the Position

The Senior Regulatory Affairs Associate / Regulatory Affairs Manager is responsible for ensuring the regulatory compliance of therapeutic products in Singapore and other South East Asia (SEA) developing and executing regulatory strategic plans and supporting product registration and managing product life cycle change in conjunction with project teams; setting the strategy for submission of clinical trial and product registration documents; and supporting clinical trial and marketing authorization activities across the BeiGene’s portfolio in SEA. Ensure compliant and uninterrupted supply of BeiGene products or the import products from collaboration partners in accordance with BeiGene’s quality management system and local country regulatory authority requirements.

Main Responsibilities
- Support the successful registration of new products and be compliant and effective with all product safety activities.
- Manage relevant maintenance activities including lifecycle management strategy.
- Primary contact with Regulatory Health Agency in Singapore, maintain and strengthen communication with relevant offices.
- Lead Regulatory Health activities through external partners in Southeast Asia.
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
- Manage and liaise with external regulatory partners to support local execution.
- Provide expert regulatory input to strategic decision-making, including portfolio review, prioritization, and external communications.
- Update and maintain standard operating procedures or local working practices.
- Maintain and update the team with the current knowledge of relevant regulations, including proposed and final regulations implementation.
- Work closely with commercial, medical, supply chain and quality to support launch and daily operation activities.
- Review and provide input on regulatory perspective in supporting promotional materials review.
- Support QA and other support functions by providing regulatory input where applicable.
- Support activities such as audits, regulatory agency inspections, medicine shortages or product recalls.

Qualification Required:
Qualification
- Life sciences degree
- Proven regulatory experience in biotechnology or pharmaceutical industry with a minimum of 5 years of experience.
- Excellent organizational and communication skills
- Strong project management skills
- Strong interpersonal and negotiation skills
- Analytical and problem-solving skills

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

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._
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