Associate Director in RA CMC - Søborg, Danmark - Novo Nordisk
Beskrivelse
The positionAs an Associate Director in Regulatory Affairs CMC & Device, you will lead a dedicated team of experienced RA Professionals and play a pivotal role in shaping and influencing regulatory strategies and getting Novo Nordisk products to market.
Your main responsibilities will be focused on:
People management and development Prioritising and forecasting resource allocation Driving regulatory strategies on innovative products together with Regulatory Leads in the department Effectively communicating our regulatory messages to relevant stakeholders Drive improvement initiatives within the department and across the RA CMC & Device area Qualifications To be a competitive candidate, you should have: A master's degree related to Life Sciences and experience working with pharmaceuticals, devices, or combination products At least five years of proven track record experience working in a large organization and/or health authorities within the regulatory affairs area or an interfacing area, e.g., CMC development, device development, manufacturing development, QA Strong people leadership and management experience On a personal level, you should be self-motivated and have a strong drive.
You bring a proactive and innovative approach to provide valuable input and support, setting the strategic direction and drive change.
Finally, you must be able to communicate complex topics to many different stakeholders and have a positive attitude and collaborative approach.
About the department The RA CMC & Device function is responsible for driving the RA strategy and submission activities for pharmaceutical, drug-device combination products and devices in development projects.
We are responsible for planning and implementing regulatory strategies based on current regulations and negotiating with authorities to ensure minimum time to market bringing innovative treatments making a difference to patients.
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 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.