Director Regulatory Affairs Rare Diseases

Are you passionate about leadership and bringing the best out of people? Do you enjoy building excellence within processes to render them effective and agile? Do you have a growth and innovative mindset to drive change in a future-ready environment? Do you like working with a lot of engaged and competent colleagues while creating a positive and healthy working environment?

Then you may be the right fit to become our new Director for the Regulatory Affairs Rare Blood Disorders department in Global Regulatory Affairs (GRA) in Søborg/Copenhagen. Read more and apply!

The Position
As a Director, you will be an active member of the Global RA Rare Diseases leadership team. You will be leading a team of Global Regulatory Leads (GRLs) and professionals assigned to projects within Rare Blood Disorders. Your regulatory team is responsible for carrying out strategic, tactical as well as operational tasks, develop long and short-term regulatory project strategies and maintenance and execute with regulatory planning excellence.

Furthermore, in the role you will also handle below responsibilities:

• Lead the department in line with Novo Nordisk Way to ensure optimal and continuous employee development, portfolio planning and resource utilisation. The team is responsible for various projects across various phases of R&D, entailing designing and executing of the most optimal global regulatory strategies. Including but not limited to   new MAA, NDA, CTAs/INDs, label creation and updates thereof, setting direction regarding the projects and portfolio strategy, actively driving and contributing to various elements of the Rare Blood Disorders Therapeutic Area Strategy (TAS), actively participating in cross-functional matrix teams with other senior stakeholders within and beyond RA.
• Accountable for efficient performance management, people development, salary, bonus, and nomination of employees for promotions and talent programs.
• Oversees daily operations of the function by directing staff and adhering to company-wide policies, priorities, procedures, and programs.
• Based on consolidated global regulatory intelligence, provide guidance for stakeholders on strategy for authority interactions on related RA activities including all 5Ds (Drug, Data, Device, Digital Health, Diagnostic) and the optimal pathway for obtaining regulatory approval for mentioned portfolio and holistic patient solutions

The position will require physical presence in our facilities in Søborg, based on hybrid-work schedule which enables you to work from home on some days.

Qualifications

We are looking for someone who has solid knowledge in Regulatory science, clinical R&D, data generation, medical and disease area understanding and ability to interpret diverse data and build strong regulatory science strategies, submission scenarios catering for patient and business needs.

To succeed in this role, you have:

•   An educational background as MD., PharmD., or PhD. 

•   12+ years of experience within key domains of R&D or global regulatory affairs.

•    Experience in Clinical Development including leading and setting direction for MAA/BLA/NDA submissions from planning through to approval from a headquarter position.
•    5+ years of proven experience as a leader with direct line reporting.
•    Possess business acumen as well as strong understanding of BD from pharma and GRA perspective.
•    Full proficiency in written and spoken English.

On a personal level, you demonstrate proactive leadership style and act with a committed, persistent, and accountable behaviour. Your strong change management skills, as well as planning and coordination skills, help you to identify problems and solutions proactively – keeping things simple and eliminate unnecessary complexity.   

As a leader you delegate and empower to encourage others to act, also by actively coaching and providing feedback. Your inclusive mindset will allow you to build trust and relationships across functions and cultures as well as your excellent communication and negotiation skills which enable you to establish trusting relationships with your team and stakeholders.

About the Rare Disease area and Rare Blood Disorders department

You will join the RA Rare Diseases area located in Søborg, Denmark and Bangalore India. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorisation applications globally as well as a portfolio of marketed products. We have a broad and expanding portfolio within Rare Disease indications that severely affect millions of people globally and with no or limited treatment options.

The area is structured with four distinct departments, each responsible for part of the Rare Disease Portfolio. The department responsible for Rare Blood disorders for which we are seeking a director to lead the department is in Søborg, Denmark and consists of 12 highly engaged employees with diverse background and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The department is responsible for development projects spanning very early development stages to late-stage development projects going into the submission phase.    

Working at Novo Nordisk

At Novo Nordisk, we do not wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact

For further information, please contact Mette Pierri Stensler-Thomsen +45 30775592. 

Deadline

16 December 2024. Relevant candidates will be invited for interview also before deadline.

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. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your resume.

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.