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Regulatory Principal Specialists/Global Regulatory Leads - Advanced therapies & Rare Disorders

Novo Nordisk A/S

Category: Regulatory Location: Søborg, Capital Region of Denmark, DK

Join Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people work with new technologies and diverse therapeutic areas 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, business acumen and the ability to navigate many agendas and stakeholders by demonstrating leadership at all levels. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department
You will join the Global Regulatory Affairs, Biopharm organization situated in Søborg, Denmark. We take pride in working with rare diseases and orphan drugs within the therapeutic areas of Rare Blood Disorders and Rare Endocrine Disorders, and we exploit the opportunities of Advanced Therapy Medicinal Products (ATMP) across several chronic disease areas in Novo Nordisk. Our projects range from early stage development to mid/late stage development to established products still active in several LCM activities. Our projects vary in range with new innovative technologies such as monoclonal antibodies, RNA interference, gene editing and DNA immunotherapy within a wide range of diseases, including but not limited to hemophilia, T1DM, NASH, sickle cell disease and various other rare and chronic diseases. We are dedicated and highly engaged employees who have strong and close collaboration with high level of trust and openness.

We work as an integrated part of global cross-functional project-teams with stakeholders ranging from research, to development, to market access, to commercial and to our Novo Nordisk affiliates worldwide. We are responsible for developing robust global regulatory strategies. We provide regulatory expertise and tactics throughout the development stages and proactively connect with the entire value chain. We drive Health Authority interactions, clinical trial applications, new drug applications, label development and provide regulatory input to due diligence.

We are looking for two Global Regulatory Leads (Principal Specialist) who have extensive regulatory and drug development expertise combined with strong scientific background, business acumen and strong leadership skills, and who have a genuine interest in being part of the future of rare diseases, orphan drugs, diverse therapy areas and new technologies, that can bring innovative medicines to patients worldwide.

The job
As a Global Regulatory Lead (Principal Specialist) you will be accountable for developing the global regulatory strategy and for applying competitive intelligence in a project. You must demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about rare diseases and orphan drug development, regulatory processes and activities related to a global development project. It is expected that you provide innovative regulatory guidance and tactics to the development path of the project.

You will represent Regulatory Affairs in cross-functional project core teams where you will be accountable for the global regulatory strategy. You will be responsible for planning 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 accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory marketing authorization submissions and approvals globally. You will regularly interact with regulators, medical specialists, researchers and commercial experts. It is expected that you take a broad perspective and are able to think throughout the value chain when proactively bringing opportunities forward, when identifying solutions, solving complex problems and when recommending solutions or best practices. All in all, with regulatory leadership you will have a large responsibility and accountability, and you will have a major influence and impact on our project development and roll out globally.

As most of the projects are in development phases, you will closely interact with Research and Development organizations and provide innovative regulatory strategic and tactical input as well as guidance 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.

Your background covers a master’s degree within life sciences with minimum of 8 years of relevant experience and/or a relevant PhD with minimum of 5 years of relevant documented working experience. From your career you have solid experience in preparing and delivering on global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally, handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You also have a strong pharmaceutical industry knowledge and business acumen. Preferably, you have experience in working with innovative technologies such as those mentioned above, as well as with rare diseases and orphan drugs. You have experience in interacting directly with regulatory authorities on an international scale.

As a person you must demonstrate proactive leadership style and 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 are skilled in training and supporting others, and you have an inclusive mindset and respect the diversity in others. You must have strong negotiation skills and a sound business understanding.

You can think out of the box and suggest unconventional solutions, and you have the ability to work with ambiguity and complexity. 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 chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.

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

5 October 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.

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Ansøgningsfrist d. 05.10.2020
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Novo Nordisk A/S - hurtigt overblik

Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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