Manager, Submissions team within New Product Introduction

Manager, Submissions team within New Product Introduction

Are you an experienced leader with strong people skills and a genuine interest in business strategy, then this position could be for you! We are offering a team leader position for the recently formed New Product Introduction (NPI) Submissions team in Novo Nordisk. As leader of this team your responsibility will be to secure delivery of the Drug Product Manufacturing sections of regulatory submissions across the entire Novo Nordisk injectables portfolio, including both Rare disease and Diabetes and Obesity.

The work of the team is high pace and high reward; the team’s success and ability to deliver translates directly to company business success, so your ability to engage, motivate and inspire the team will have a direct and tangible impact on Novo Nordisk. If you think this sound interesting and you are up for the challenge, you could be our new Manager for the NPI Submission teams in Aseptic Manufacturing Science & Technology (AMSAT).

The Position

As Manager of the NPI Submissions team you will be leading 10-15 dedicated regulatory writers. The teams’ main task is to write the Drug Product sections of regulatory submissions (NDAs, BLAs, renewals, variations) and handle the Q&As that follow to ensure the successful approval of Novo Nordisk’s injectable products world-wide. The work is critically dependent on a very strong cross-organizational collaboration with Subject Matter Experts in our sister areas in AMSAT and with Regulatory affairs. Through this work, the team has a huge impact on the success of launch and life cycle management of injectable products within Novo Nordisk’s full product portfolio.

Your main tasks will be to:

• Drive innovation and efficiency within the team, ensuring the prioritizations are clear, strategies are executed, and timelines met.
• Lead the team, incl. employee engagement, define individual business and behaviour goals, ensure hiring and job training, champion personal and professional development, as well as manage regular follow-up on project task progress.
• Allocate and manage resources from the team to key projects
• Collaborate with a large internal and external stakeholder landscape to ensure seamless flow of writing and reviewing and success across the company. 

As a person you are open, honest, and curious, and you enjoy seeing your team shine and succeed through collaboration and teamwork. You are structured, set tangible goals and communicate them clearly, ensuring that everyone knows how to be a success, and what the priorities are. You enjoy working through complexity and have a keen interest in strategy and a holistic mindset that enables you to work effectively across organizational boundaries.

Qualifications

To succeed in this role, you have:

• An academical background in sciences, engineering, pharmacy or similar.
• A solid leadership background within product development or pharmaceutical production. Experience with (aseptic) manufacturing processes and regulatory submissions can be an advantage.
• Experience with change management is a definite plus.
• An ability to balance short term deliverables with long term focus, prioritizing and creating transparency for your team.
• Effective communication and collaboration skills.
• Fluency in English language.

You enjoy working with people, have excellent people skills, and are always looking for ways to improve and develop your leadership abilities. You inspire and energise your surroundings, set clear and ambitious goals, and generally lead with empathy and behavioural role-modelling.

You know the value of building relations and earning trust and respect from colleagues and employees. You work to bridge cultural, professional and geographical distances, focusing on how to reach sustainable solutions in an ever-changing environment. We encourage you to apply even if you do not meet all the listed qualifications but possess relevant skills and experience.

About the area/department

In Aseptic Manufacturing (AM) we produce our many high-quality injectable products for diabetes, bleeding disorders, growth hormone, and obesity, and the AMSAT organisation is a global function, supporting all our manufacturing sites worldwide with process, product, and analytical expertise. New Product Introduction (NPI) consists of 90 employees, and we are currently located in Søborg. The main responsibility of the area is the transition of development drug products into large scale production. This includes production design, material and process sciences, product stability incl. specification setting and trending, coordination of manufacturing for late-phase clinical trials, and filing for market approval with health authorities.

The Submissions team is part of the Submissions and Reference Materials department in NPI and was formed at the start of 2025. The team provides support with regulatory writing across three areas within AMSAT, Product Life Cycle Management, Manufacturing Science and Transfers and NPI. The team consists of a group of regulatory professionals and submission specialists each being a key part of securing approval of new drug products and launch in the market.

Working at Novo Nordisk 

At Novo Nordisk, we don’t wait for change. We drive it. We’re 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, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

What we offer

As a global healthcare company with a unique culture and strong results,  we offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary:  For this role, the Annual Base Salary ranges from 742,600 to 1,091,600  DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Contact 

For further information you are welcome to contact the hiring manager: Maria Berggård Silow on phone +45 34 48 50 56

Deadline 

Please apply before 16 June 2026. 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.

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