Regulatory Specialist - RA Advanced Therapy Medicinal Products

• Regulatory
• Søborg

Join Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people work with new and exploratory technologies to bring innovative medicines to patients across the globe. Our people in Regulatory Affairs have a unique combination of scientific and regulatory insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department

The department of Advanced Therapy Medicinal Products is a newly established unit within Regulatory Affairs in Novo Nordisk. We work on early development projects with focus on new innovative technologies such as RNA interference, gene editing and DNA immunization within a wide range of diseases, including but not limited to hemophilia, T1DM, NASH, and sickle cell disease. We are currently four dedicated and highly engaged employees working in the department.

We work as an integrated part of global cross-functional project-teams with stakeholders ranging from research to market access. We are responsible for the regulatory strategy, and we provide regulatory expertise and tactics to the product development. We drive Health Authority interactions, clinical trial applications, new drug applications and label development.

We are looking for a Regulatory Specialist with a strong scientific background combined with extensive regulatory and drug development experience who has a genuine interest in being part of the future of new technologies that can bring innovative medicines to patients worldwide.

The job

As Regulatory Specialist you will be responsible for developing the global regulatory strategy and for applying competitive intelligence for a project. You will represent Regulatory Affairs in cross-functional project core teams where you will be responsible for planning, executing and driving all regulatory activities and deliverables according to agreed timelines and quality. You will furthermore lead global regulatory teams for various projects in the department.

You will be the overall responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions, and for regulatory submissions and approvals. You will interact with medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact.

As most of the projects are early in development, you will closely interact with Research and provide innovative regulatory guidance and tactics to the development path of the new modality products. You will assume the role of the challenger who makes an impact, seeks solutions and drives innovations.

You will report to the Manager of RA Advanced Therapy Medicinal Products and take active part in department related activities, including improvement projects across RA.

Qualifications

Your background covers an MSc within Biology or Health Science and a relevant PhD or similar documented scientific qualifications. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. Preferably, you have experience in working with innovative technologies such as those mentioned above, either through research or within regulatory affairs. You have experience in interacting directly with regulatory authorities on an international scale. You have proven strong negotiation skills and you have a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.

As a person you can think out of the box and suggest unconventional solutions. You are well organized and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You have a good sense of humor, and you can keep your spirits high even when under pressure. You are an excellent communicator who can cooperate and influence at any organizational level. Finally, you are comfortable using your fluent written and spoken English daily.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Tara Elvang at +45 3075 2456.

Deadline
1. Marts 2020.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.