Regulatory Affairs Regional Lead

Are you looking to be part of one of the fastest-growing regions in [xxxxx] and shape the future today? Do you thrive in an environment where change is daily and the unexpected is routine? If you answered yes, then apply now!
We are seeking a Regulatory Lead based in Denmark to join us on our transformative journey to accelerate the highly dynamic and diverse APAC region.
The position
[xxxxx] is committed to ensuring commercially viable access to our medicines for those who need them. As a Regulatory Lead, you will play a crucial role in creating regulatory strategy and implementation plans for specific therapeutic areas to ensure speed to market in the region. You will also be responsible for developing an affiliate-level project management approach to New Drug Applications (NDAs), Life Cycle Management, and managing communication on shortages/interrupted supply on designated projects/products in targeted region markets. Additionally, you will:
• Contribute to regulatory intelligence by staying up-to-date with the evolution of regulations relating to your projects and in the major APAC markets and advise on any regulatory requirements that may impact the projects and the planning in the different countries.
• Work closely with different internal and external stakeholders such as RA in Affiliates and Global/IO, Clinical, Commercial teams in Region APAC and Affiliates, Health Authorities in Affiliates, Supply Chain, and Product Supply.
• Support the Regional Regulatory Affairs & PV Director in regulatory matters and initiatives across APAC.
• Be responsible for creating the best regulatory strategies, labelling claims, and supply flexibility by linking local needs and priorities to ensure speed to market and drive optimal product approvals and major changes to ensure uninterrupted supply with the strategic vision and business objective of the Region. Qualifications
We are seeking someone with a good understanding of the global business model of a pharmaceutical company. It is essential that you are able to work independently, have excellent networking and communication skills, and can build internal and external coalitions. Additionally, you must have:
• A University degree (Pharmaceutical, medical science-related field, or relevant business orientation), a relevant Post Graduate degree e.g. PhD, MBA, or MSc is desirable.
• R&D experience in the pharmaceutical industry and/or academia, mainly in the regulatory affairs area.
• A strong pharmaceutical business understanding, including solid analytical skills, e.g. analysis of regulatory options and risks.
• Experience in project management and strategic planning with precision and flawless execution.
• Previous strategic and product portfolio experience across multiple countries is advantageous.
About the Department
[xxxxx]'s Region APAC is one of the seven regions of the International Operations and encompasses 20 markets located in Asia and Oceania. The regional office for APAC (Asia, Pacific) is located in Dubai, where you will work alongside remotely from Denmark.
Working at [xxxxx]
[xxxxx] is its people. We understand that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at [xxxxx] is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life-changing.
Contact
For more details, please contact Natalia Morgunova at [xxxxx]
Deadline
Please apply before the 21st June. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.