Regulatory Affairs Consultant

Regulatory Affairs Consultant

Use your pharmaceutical experience to transform Regulatory Affairs

NNIT is looking for Consultants with a deep pharmaceutical expertise and regulatory insight keen on making a mark on some of the most exciting digital transformations projects within the Life Sciences industry. The NNIT Life Sciences Consulting team is at the forefront of consultancy support to an array of global pharmaceutical companies. Are you our new colleague?

Your responsibilities as a Regulatory Affairs Consultant

You will join an exciting, international consultancy with highly skilled colleagues that have a deep understanding of the life sciences industry and the ability to bridge this knowledge with IT. Working closely with international clients, you will use your experience from regulatory Affairs to advise and assist companies in a vast array of projects, spanning from RA process optimization to various regulatory changes sparked by new authority requirements. You will be expected to give clients advice on vendor selections for new digital solutions within the area of electronic document management systems (EDMS), eCTD, labelling and regulatory information management systems (RIMS). It’s a benefit if you also have knowledge about Pharmacovigilance or Medical Device processes and systems. A key part of the job is business development activities related to new offerings that will support our continued growth within the areas of Regulatory Affairs and Pharmacovigilance. The job will include close collaboration with a multitude of stakeholders within NNIT where your business domain knowledge will strengthen our companies' strategic aspirations in Regulatory Affairs. You will also be expected to give presentations and speaker sessions at conferences as well as writing articles about our endeavors and expertise when it comes to digitalization of Regulatory Affairs.

You will be part of NNIT’s Life Sciences Consulting

NNIT’s Life Sciences Consulting is an ambitious department with a key importance to NNIT’s strategy. We appreciate openness, honesty and a winning attitude. We expect you to have these personal skills and expect that you can quickly integrate with the other team members. Our customers expect us to know about upcoming trends and regulatory changes, as well as being on the forefront of digital solutions. Your career will include continuous training and competence development to support our department and your personal ambitions. NNIT was recently nominated as the most attractive workplace within the IT consulting area in Denmark.

Your qualifications and experiences

• You hold an MSc degree in Life sciences or IT with 3-5 years of experience from the life sciences industry (preferably Regulatory Affairs).
• You have an interest in and an understanding of IT, and you manage to bridge your professional experience from the life sciences industry with IT.
• It is an advantage if you have experience with Regulatory business processes and how digitalization can support business process efficiency.
• From your previous positions and gained experience, you know that a winning personality will help you build trust and enable great customer engagement.
• NNIT has offices in Copenhagen, Frankfurt and Basel, and we will expect you to live in the proximity of these pharma hubs.

Fluency in oral and written English is a must. German, French and/or Danish is beneficial. Travel must be expected.

About NNIT Regulatory Affairs

The NNIT Group provides a wide range of IT and consulting services to the global life science industry and has been a trusted partner to life science companies for +25 years.

We are a leading global RA advisory and consultancy organization committed to digitally transform Regulatory Affairs into an influential strategic and data driven business unit.

We leverage thought leadership knowledge and the newest technology, with implementation excellence and successive maintenance service.

• Leading Regulatory affairs service provider recognized by industry peers in the Gens and Associates Rim Benchmark reports
• Diverse team spanning across 10 different nationalities, more than 60+ team members with a balanced share of male and female colleagues
• We work with leading pharma and biotech companies and support in driving the digital transformation agenda across the RA organization
• Highly specialized in RIM implementations and IDMP services
• We offer the ability to use your industry expertise in building innovation in RA by working with tech savvy colleagues
• Ability to learn and grow by being part of internal community of practices focused on Regulatory Affairs and not only.

What’s next?

If you recognize yourself in one of these roles, we’ll be looking forward to hearing from you. We hire candidates continuously, so we encourage you to submit your application as soon as possible.

Apply now and make your mark!

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