Are you ready to shape the regulatory pathway that brings life-changing medicines to millions of patients across Southeast Asia? Do you thrive at the intersection of strategy, science and stakeholder influence? If you want to drive accelerated access to innovative therapies in one of the world's most dynamic regions, read on and apply today. Your new role As our Senior Regulatory Affairs Manager for Business Area Southeast Asia (BASEA), you will design and drive the regulatory strategy that accelerates patient access across the region. Based in Malaysia, you will be the strategic regulatory voice for BASEA — partnering with affiliates, APAC, International Operations and Global Regulatory Affairs to shape submissions, approvals and lifecycle activities across our entire portfolio, with a strong focus on cardiometabolic assets. Day-to-day, your responsibilities will include: <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Developing the BASEA regulatory strategy to secure early market access for New Drug Applications (NDAs), major line extensions and critical lifecycle management (LCM) activities</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Representing Regulatory Affairs at the BASEA management level, flagging risks, opportunities and upsides to influence strategic direction</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Driving optimal labelling claims through review of CCDS, EU SmPC and local PI/labels to support advantageous commercial positioning</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Guiding affiliates in pursuing accelerated regulatory pathways (reliance, fast track, abridged) and supporting risk and issue management with health authorities</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Provide strategic and tactical regulatory input to develop the portfolio LCM plan to enable supply mitigations and/or optimizations.</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Help map and elevate regulatory advocacy capabilities & strategies across southeast Asia</li> </ul> Your new department You will join the BASEA Regulatory Affairs team covering Southeast Asia — a fast-moving, high-impact part of our APAC region. You will work closely with affiliate regulatory teams, commercial, medical, market access, clinical, legal and CMC colleagues to ensure aligned, efficient and forward-looking regulatory execution. This is a role where your decisions directly shape how quickly patients across BASEA can access transformative therapies. Your skills & qualifications We are looking for a strategic, driven regulatory professional who can navigate complexity, build coalitions and operate independently in a less-defined project environment. You will bring: <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">A university degree in pharmaceutical or medical sciences, or a relevant business-oriented field; a postgraduate degree (PhD, MSc or MBA) is desirable</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">5+ years of regulatory affairs experience, complemented by 5+ years of R&D experience in the pharmaceutical industry or academia</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Strong pharmaceutical business understanding and proven regulatory analytical skills, including the ability to assess regulatory options, risks and accelerated pathways</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Demonstrated experience in project management and strategic planning, with a track record of precise and flawless execution, plus the ability to work independently</li> <li style="margin:0.0cm 0.0cm 6.0pt 0.0px;line-height:14.0pt;font-size:10.0pt;font-family:'Apis For Office', sans-serif;color:black">Strong networking, influencing and communication skills with fluency in written and spoken English, and willingness to travel within BASEA and to affiliates as required</li> </ul> Working at Novo Nordisk For over 100 years, we've been dedicated to defeating serious chronic diseases, and this shared sense of purpose transforms our daily work into meaningful impact. Here, you'll be part of a culture built on mutual respect and collaboration, where diverse perspectives drive innovation and everyone's contribution matters. As we continue our remarkable transformation into a global healthcare leader, you'll find exciting opportunities to grow your career in new directions. This is where commercial excellence meets genuine purpose – where your ambition and our collective dedication create lasting change for long-term health. Contact Kindly send your CV online (click on Apply and follow the instructions). Deadline 24 Jul 2026We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Senior Regulatory Affairs Manager (Kuala Lumpur, Kuala Lumpur, MY) @ novonord

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