Regulatory Affairs Manager - Zürich, Schweiz - Novo Nordisk

Beschreibung

The position

In this exiting new position, we are seeking a detail-oriented Regulatory Affairs Manager and a strategic thinker, to lead registration tasks and ensure compliance with Swissmedic regulations.

Your main responsibilities will include:
Development and assessment of regulatory strategies for development projects and Life Cycle Management. Compilation of documentation for new registrations, registration transfers, variations, and revisions.

Close collaboration with internal and external stakeholders to to develop and implement regulatory strategies that support product development and commercialization goals.

Management of drug safety signals, including informing stakeholders and implementing changes into local labels.

Qualifications You have decided to apply for this exciting opportunity because you already have several years of experience as a Regulatory professional in the pharmaceutical space in Switzerland or the DACH Region, and you are eager for a new challenge Furthermore, Proficiency in English is a prerequisite, with an advanced level of proficiency in German, and fluency in French is considered advantageous.

You will have advanced knowledge of regulatory system, government guidelines and pharmaceutical industry in general.

You will have a university degree in Pharmacy or Science with impressive stakeholder management skills You are very detailed and work accurately and you pride yourself with your great organisational skills.

About the department Novo Nordisk Pharma AG is the Swiss Affiliate, with over 90 employees, dedicated to making a remarkable difference to patients across the country.

Located at the Circle, Zurich Airport. The Swiss Affiliate belongs to Region North West Europe, which is part of IO (International Operations). 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.