Drug Regulatory Affairs Partner

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position
The Opportunity

Roche Pharmaceuticals A/S is looking for a committed and energetic Drug Regulatory Affairs Partner with a structured and quality-oriented mindset.

We offer a challenging and varied job in an active and flexible working environment, where you will have independent responsibility for driving regulatory tasks and making impact for our business. As a Drug Regulatory Affairs Partner, you will be part of a small team of dedicated regulatory, QA and compliance employees, who work in a self-managed team with regulatory, GxP and compliance tasks often with short deadlines.

Your responsibility:

• Being regulatory responsible for assigned products in Denmark and Iceland.
• Coordination and preparation of document packages for regulatory submissions for new products and Life Cycle Management submissions to registered products.
• Proof reading of regulatory texts in local language.
• Responsible for artworks changes related to Lifecycle Management, this includes initiating, manuscript creation, proofreading and approval of artworks.
• Make sure corporate regulatory data and document management systems are up to date.
• Keeps abreast of regulatory legislations, procedures and changes to the regulatory landscape to secure compliance at all times.
• Have direct interaction with regulatory agencies.
• Actively interact and support the business and disease area teams with regulatory details, timelines and information related to products to support business and launch activities.
• Work with the Roche HQ to coordinate and support Scientific Advises with the Danish Health Authorities, where Denmark acts as Rapporteur Country for EMA.
• Responsible for implementing new systems and training new colleagues.
• Maintenance of procedures to secure compliance to regulatory legislation.

Who you are

• You have a master's degree in pharmacy, pharmaceutical sciences or a related fields.
• Have a strong personality and thrive to work in a regulated area
• You are systematic in your way of working, you are flexible and you have strong interpersonal skills
• You are a team player, that can work both independently and cooperate effectively with others.
• You are able to speak up and express yourself effectively in Danish and English, both spoken and written.

You are welcome to contact Sandra Stendal, Head of License to Operate on +45 24 88 60 52 for further information.

Om Roche Pharmaceuticals A/S

Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.
Location: Copenhagen