Regulatory Professionals (CMC) – permanent and temporary positions
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight.
We are currently looking for two regulatory professionals with an experience and interest in Chemistry, Manufacturing and Controls (CMC) to join our team Regulatory Affairs – Diabetes and Obesity Projects, where you will have 10 dedicated colleagues. The open positions are a permanent and a 1-year temporary position. As Regulatory Professional you will coordinate the regulatory CMC activities needed to ensure both the development of novel therapeutics and to maintain our licenced products.
Challenges
You will be responsible for activities involving colleagues situated on site in Søborg, at other Danish sites, and at Novo Nordisk’s affiliates abroad. In your projects you coordinate the CMC aspects of the regulatory affairs discipline. You will be involved in all aspects of the discipline such as regulatory strategies, clinical trial applications, submission, approval and maintenance of worldwide applications and other interactions with health authorities. In your work you focus on linking CMC development opportunities to regulatory requirements for our innovative projects within diabetes and obesity and to secure supply of a marketed product. At all times, you seek to secure quality of the documentation submitted to health authorities, and to this end, RA associates and specialists in the organisation will support you.
You will represent Regulatory Affairs in the CMC core team of designated projects or products. Here, you ensure regulatory CMC deliverables according to agreed time, cost and quality. You will assume the role of the proactive advisor regarding regulatory opportunitues and risks related to CMC activities. You report to the Department Director and in your daily work you are expected to contribute constructively to internal teams comprising other regulatory professionals and associates as well as the Regulatory Project Manager who is overall responsible for the regulatory input to your projects.
Qulifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs in the pharmaceutical industry preferably within CMC related to biological compounds. You are required to have thorough technical understanding of CMC including the regulatory requirements in the field.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work – even under pressure. You are a dedicated team player, but you also enjoy working independently and find new solutions to the challenges you meet. You are a skilled communicator who is comfortable speaking and writing in English.
Contact
If you have any questions please contact Lars Wichmann Madsen tlf. +45 3079 0921.
