Novo Nordisk

Senior Regulatory Affairs CMC Professional

Fuldtid

Permanent

Gladsaxe

SE PÅ KORT

ID: 2593828

Indrykket for 16 dage siden

Do you have experience from either RA, CMC, QA, and/or QC – or any other relevant area? Do you possess a natural interest and flair for regulatory guidelines? Do you enjoy being part of a team where you together build and work on the timely delivery of successful submissions? Then you might be one of the people we are looking for.

Novo Nordisk Regulatory Affairs CMC & Device (RA CMC & Device) is on a fortunate journey with our organization growing and expanding because of a developing and flourishing Novo Nordisk product portfolio. We are therefore seeking several RA CMC professionals to support the RA CMC work across different stages of projects in different indications.

Apply now for a life-changing career!

The Position

As a Regulatory Affairs CMC professional, you provide the key connection between scientists and regulators to make medicines available to patients around the world by ensuring fast and successful regulatory submissions and approvals in all global markets.

Your responsibilities will include:

You will join an organization where there are opportunities to work across the various phases of clinical development, including early and late-phase clinical studies, planning, and executing meetings with the health authorities, and QnAs, and submitting marketing authorization applications.

Operating as a senior RA CMC professional you will be in the center of project planning and execution – responsible for participating in establishing realistic – and at times bold – RA strategies.

You will Together with the project team, you will be planning and due diligently to ensure timelines are met.

A cornerstone in the RA CMC operation is the coordination and review of regulatory documentation packages, including also supporting the preparation of applicable sections of submission packages, responses to agency questions, and agency meeting packages.

You will be part of an RA CMC project team and a project core team. In the project team, you will be responsible for giving input from the RA CMC perspective and participating in establishing submission timelines and support decisions on the extent of data needed for a filing to receive HA approval.

Additional aspects of the role include identifying as well as improving regulatory CMC practices, processes, and approaches related to regulatory CMC documentation and strategies.

Qualifications

You come with a scientific background and mindset, which you have acquired through your extensive experience in pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance, and other related areas.

The ideal candidate should have:

Master's degree and/or PhD in a relevant field

At least 5 years of relevant experience within the pharmaceutical industry

High proficiency in English - written as well as spoken

Great communication skills as all work takes place in multidisciplinary project groups

A pro-active, positive, and friendly professional style

Enjoy being part of teams with people from diverse backgrounds

You are a dedicated team player, you find it easy to build working relationships and gain recognition amongst stakeholders with your proactiveness and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures.

About the Area and Department

RA CMC & Device consists of six areas with three working specifically with RA CMC functionality. We are skilled, collaborative, friendly, and dedicated colleagues with diverse backgrounds and experience, and you will be part of a dynamic and committed organization handling many projects in different phases of development. Also, as Novo Nordisk’s product portfolio grows, RA CMC & Device is also looking into developing innovative solutions to increasingly complex CMC manufacturing strategies and regulatory requirements.

There is a high focus on individualized onboarding, flexibility, empowerment, and individual development in the area. Well-being and psychological safety are also a major focus and are considered essential for the working environment. We strive for a modern way of working, including friendly colleagues, camaraderie, and space to be proactive, to learn, and to take the initiative to improve and make a difference. We want it to be the best place to work – not only in words, but we walk the talk in this area.

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work.

Visit our Regulatory Affairs Careers webpages

For more information about job content and qualifications, please visit the Novo Nordisk Regulatory Affairs Careers webpages at regulatory-affairs-careers.html

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