Regional Regulatory Lead - APAC

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Do you have expert knowledge within Regulatory Affairs combined with solid pharmaceutical business understanding, project management and stakeholder management skills? Do you want to be part of a global team and drive the strategic vision and business objective within our APAC region? And do you wish to make an impact and ensure the timely delivery of our products by creating regulatory strategies and plans and execute on them? If so, then this opportunity could be right for you. Apply today!

 

The position is located in Copenhagen, Denmark with regular travelling to our APAC office in Dubai and some travelling around the APAC region.

 

The position

Novo Nordisk is dedicated to securing commercially viable access to our medicines for the patients who need them.  You will be a key contributor to create Regulatory Strategy and Implementation Plans to secure speed to market in the region as well as the development of Affiliate level project management approach to New Drug Applications (NDAs) and Life Cycle Management on designated projects/products in targeted region markets.

 

Your responsibilities will include:

  • Recommending best regulatory strategies to PPT, to ensure speed to market
  • Drive optimal and timely product approvals and labelling claims of the designated projects/products in assigned markets
  • Linking local perspective with the strategic vision and business objective of the Region
  • Support Regional Regulatory Affairs Head in regulatory matters and initiatives across region and represent Region in Global Regulatory Portfolio Teams

 

You will contribute to Regulatory intelligence by ensuring an oversight of the evolution of regulations relating to your projects and in the major APAC Markets and advise on any regulatory requirements which may impact the projects and the planning in the different countries. In consultation with Global Regulatory Leads (GRLs) you will develop and execute regional strategies and contribute to global regulatory strategies/plans.  Submitting regulatory applications for development products and change applications for registered products to obtain HA approval in the fastest and most efficient way, will be your responsibility as well.

 

Qualifications

You hold a Master´s degree or Ph.D. degree within Pharmaceutical, Biology, Biochemistry, Engineering, Medical science or have a business-related degree, such as MBA.

 

In addition, to succeed in this role, you have:

  • Minimum 3-5 years of R&D experience from the pharmaceutical industry and/or academia
  • Strong pharmaceutical business understanding including solid understanding of regulatory analytical skills, e.g., analysis of regulatory options and risks
  • Solid project management skills and strategic planning with precision and flawless execution
  • Ability to work independently, have good networking and communication skills and are able to build internal and external coalitions.
  • Fluency in written and spoken English.

 

You are curious about people and can interact with many different stakeholders in a complex and highly dynamic environment on a daily basis. You enjoy driving impact and change through people with various cultural backgrounds. You communicate flawlessly and quickly build new relations.

 

About the Department

Novo Nordisk’s Region APAC is one of the 7 Regions of the International Operations and encompasses 20 markets located in Asia and Oceania. APAC RA strives to be an important strategic partner to the business. Getting better speed to market through faster regulatory pathways, driving regulatory advocacy, and capturing signals are some of the goals to ensure that the diverse and changing regulatory environment is handled appropriately. All of this is driven through different initiatives and projects that align with APAC Accelerate ambitions: 'Bringing innovative treatments faster to markets'.

 

Working at Novo Nordisk

We are world leaders in diabetes care and pioneering other therapy areas such as obesity and NASH. Our goal is to improve the lives of millions of people around the world, every day. That is why we keep the patient in focus while never losing sight of the bigger picture. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

 

Contact

For more information, please contact Regulatory Affairs Director, Samia Seghouani, on +971 44533298.

 

Deadline

31 August 2022

 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

 

#LI-AMS1

 

 

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk 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.