Regulatory Affairs Manager (APAC, Oncology)

A leading global pharmaceutical organisation is seeking a Regulatory Affairs Manager specialising in Oncology for the Asia Pacific region. This is an exceptional opportunity to play a pivotal role in shaping regulatory strategies and supporting the development of innovative oncology therapies across multiple APAC markets. As part of a highly collaborative global team, you will be instrumental in ensuring that life-changing treatments reach patients efficiently and compliantly.

What you'll do:

As a Regulatory Affairs Manager Oncology Asia Pacific, you will play a central role in driving successful registration strategies for an innovative oncology portfolio across several APAC countries. Your day-to-day activities will involve close collaboration with both internal teams—spanning global headquarters to local affiliates—and external partners. You will be responsible for preparing high-quality submissions tailored to each market’s requirements while tracking critical milestones such as NDA reviews. By proactively identifying potential challenges in the regulatory landscape and contributing thoughtful solutions, you will help ensure that promising therapies reach patients without unnecessary delay. Your ability to manage complex data systems and communicate effectively with diverse stakeholders will be essential as you represent the regulatory function within cross-functional teams. This position offers you the chance to make a tangible impact on patient outcomes while growing your expertise in one of the most dynamic therapeutic areas.

• Collaborate closely with global, regional, and local regulatory counterparts to ensure that comprehensive regulatory strategies are defined and executed effectively for all oncology projects within your area of responsibility.
• Establish strong working relationships with regional regulatory affairs, quality assurance, supply chain, and local regulatory colleagues to facilitate seamless project execution and information sharing.
• Plan and coordinate the preparation of detailed regulatory review submissions to selected Asia Pacific health authorities, supporting the global regulatory lead or their delegate on assigned oncology products.
• Support the identification and assessment of potential regulatory risks associated with assigned projects, assisting in the development of robust strategies to mitigate these risks proactively.
• Track intricate details related to new drug application (NDA) review timelines to ensure timely submissions and responses throughout the product lifecycle.
• Monitor health authority information requests closely and participate actively in developing comprehensive team responses for submission to relevant agencies.
• Represent the regulatory function as needed within regional brand teams, engaging with key stakeholders across multiple departments at all organisational levels.
• Interact efficiently with external contacts such as consultants, contractors, corporate partners, and regulatory agency personnel to facilitate smooth communication and project progress.
• Manage complex regulatory data and information within internal systems to maintain accuracy, compliance, and accessibility for all stakeholders involved.

What you bring:

To excel as a Regulatory Affairs Manager Oncology Asia Pacific, you will bring substantial experience navigating complex pharmaceutical regulations across multiple APAC markets. Your background should include direct involvement in life cycle management applications as well as preparing detailed submissions tailored to various health authorities’ expectations. Multilingual communication skills will enable you to build rapport with colleagues and regulators alike. A deep understanding of oncology product requirements will set you apart as you interpret evolving guidelines and contribute meaningfully during interactions with external agencies. Your proven ability to organise large volumes of data while maintaining meticulous attention to detail ensures compliance at every stage. Above all, your collaborative spirit and clear communication style will foster trust among team members as you work together towards shared goals.

• 5-7 years of hands-on experience in pharmaceutical regulatory affairs within the Asia Pacific region, specifically including Taiwan, South Korea, or China.
• Demonstrated expertise managing life cycle management applications for pharmaceutical products from initial submission through post-approval phases.
• Proven track record preparing comprehensive regulatory submissions such as INDs, CTAs, NDAs, BLAs or MAAs along with supportive amendments or supplements.
• Experience interpreting regulations, guidelines, and policy statements relevant to pharmaceutical product registration within APAC jurisdictions.
• Direct exposure to oncology therapeutic area regulations is highly desirable; prior interaction with relevant health authorities is considered advantageous.
• Familiarity with US or EU regulatory frameworks would be beneficial but not mandatory for success in this role.
• Exceptional organisational skills enabling effective prioritisation of workload amidst competing deadlines and complex project requirements.
• Excellent interpersonal communication abilities allowing you to collaborate harmoniously with cross-functional teams at all levels.

What sets this company apart:

This organisation stands out for its unwavering dedication to advancing healthcare through cutting-edge research and compassionate patient care. Employees benefit from a culture that emphasises inclusivity, knowledge-sharing, and mutual respect—creating an environment where everyone’s voice is heard. Flexible remote working options empower staff to achieve balance between personal commitments and professional ambitions. The company invests heavily in ongoing training opportunities so that every team member can continue learning throughout their career journey. Supportive leadership encourages open dialogue while recognising individual achievements within a communal framework. By joining this team, you become part of a global network committed not only to scientific excellence but also to nurturing talent from under-represented backgrounds—ensuring that diverse perspectives drive meaningful progress in oncology treatment worldwide.

What's next:

If you are ready to take your expertise in regulatory affairs oncology to new heights within an inspiring international environment, this is your moment!

Apply today by clicking on the link provided—your next rewarding career move awaits.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C