Drug Shortage Regulatory Affairs Director

Are you ready to lead the way in one of the critical areas of Regulatory Affairs (RA) and make a substantial impact on patients, business and in the pharmaceutical industry? Do you have what it takes to effectively oversee any project? Would you like to join the ranks of Novo Nordisk, a renowned global pharmaceutical company?

We have recently created a Drug Shortage Unit within Global RA under Global RA Semaglutide and GLP-1 and are actively searching for an accomplished Regulatory Affairs Project Director to champion pivotal initiatives. If this aligns with your career aspirations and experience, we encourage you to submit your application today!

The position

Your main tasks include:

• Set strategic direction to drive all critical Health Authorities interactions and regulatory communications in relation to supply of medicines and drug shortages 

• Ensure regulatory compliance to drug shortage and supply requirements and integration of drug shortage regulatory reporting in GRA (Global Regulatory Affairs) process landscape

• Provide regulatory input, training, and strategic guidance to key cross-functional stakeholders in supply chain, commercial, communication, legal, safety and RA for all drug shortage and supply related issues

• Engage strategically with internal and external stakeholders, securing timely communication and regulatory reporting

• Support the design and development of robust processes to handle future trends and needs in the regulatory communication of drug shortages and medicines supply

Qualifications

We expect an ideal candidate to have:

• Master of Science degree in life sciences, pharmaceutical science, or a related legal field, coupled with +8 years of relevant experience

• Solid leadership skills with proven work history of managing teams and cross-functional teams

• Profound expertise in managing pharmaceutical supply issues (IMP)

• Strong competence in regulatory affairs, late-stage development, lifecycle management (LCM), health authority interactions, regulatory intelligence, and pharmaceutical supply

• Fluency in written and spoken English

In this job opportunity, we are looking for an individual who embodies proactive leadership and accountability. Someone whose expertise is in change management, problem-solving, and stakeholder management. 

Strong planning and coordination skills are essential, as well as the ability to handle pressure, build trust, motivate, and support your team. Additionally, you should demonstrate integrity, innovative thinking, effective goal setting, and a profound understanding of the therapy area to make a significant impact on the business.

About the department 

RA Semaglutide & GLP-1 is responsible for defining and driving regulatory strategies for our Semaglutide and GLP-1 portfolio projects in all phases of development. We are dedicated and highly engaged employees in the department belonging to the RA Semaglutide & GLP-1 area. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. Our department is responsible for Semaglutide and Liraglutide regulatory strategies and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams. 

Working at Novo Nordisk 

We are a proud life-science company, and life is our reason to exist. We are inspired by life in all its forms and shapes, difficulties, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we are all here - to ensure that people can lead a life independent of chronic disease. 

Contact 

For any further information, please contact Emel Mashaki Ceyhan at +45 34481007.

Deadline 

07 October 2023. 

Applications will be evaluated on an ongoing basis, and you may be contacted before the deadline. We look forward to receiving your application and welcoming you to our team!

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.

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.