Principal Advisory Consultant in Regulatory Affairs and Safety

In NNIT RA, we guide our customers through the digital business transformation; with knowledge, experience, dedication, and trust, we help our customers impact patients’ lives.

We are looking for a principal consultant with deep Regulatory Affairs expertise who wishes to make a mark on some of the most exciting digital projects in the Life Sciences industry.

The NNIT Regulatory Affairs Advisory team is at the forefront of supporting global pharmaceutical and medical device clients on the latest digital trends within Regulatory Affairs and Safety. Are you driven by passion for assisting RA and Safety with technologies? Then you will want to be our new colleague.

Your responsibilities as a Regulatory Affairs advisor

You will join an exciting, international advisory department with highly skilled colleagues that have a deep understanding of the industry and the ability to bridge this knowledge with digital technologies and Cloud solution such as Veeva Vault.

Working closely with clients, you will use your experience from Regulatory Affairs or Safety to advise and assist companies in a vast array of projects, spanning from process optimization to new digital tools implementation. You will be expected to advice clients on new IT solutions within the area of electronic document management systems (EDMS), eCTD, labelling and regulatory information management systems (RIMS), including IDMP. You may also have knowledge of Pharmacovigilance or Medical Devices processes and systems.

A key part of the job is business development activities related to engaging with primarily DK-based clients to provide growth within the area of Regulatory Affairs and Safety in Denmark.

You will be part of NNIT’s Regulatory Affairs Advisory

NNIT’s Regulatory Affairs Advisory is an ambitious department with a key importance to NNIT’s strategy. We appreciate openness, honesty and a winning attitude.

Our customers expect us to know about upcoming trends, as well as they expect us to be at the forefront in terms of technical solutions.

Your career will include continuous training and competence development to support our department and your personal ambitions.
Furthermore, our working culture focuses on:

• Positive work life balance where you self-design your workday with remote and flexible working hours giving you the possibility to be your best at the office and at home
• Social face to face and virtual interactions with colleagues across EU and US

Your qualifications and experiences

• You hold an MSc degree in Life sciences, Business or IT with 5+ years of experience from the life sciences industry, preferably Regulatory Affairs and/or Safety.
• You have an interest and 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.
• You are used to advice and build trust on all levels, and you might have gained this experience from a past job within the consulting area.
• From your previous positions and gained experience, you know that a winning personality will help you build trust and enable great customer engagement.
• Experience with agile delivery such as SAFe is an advantage.
• Fluency in oral and written English is a must.

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 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.

• Rated as Leading RA Consultancy by GENS & ASSOCIATES
• Rated as the IT consultancy house with Best Business Know-How and Best Implementation Skills by MyResearch in DK 2022
• First Veeva Premiere Services Partner and rated leading implementation partner by Everest Group
• 100+ RA dedicated consultants in DK, CH, DE, CN, US, PL, UK
• 30+ Current RA clients, incl. several tier 1 pharma clients
• 3000+ Employees in NNIT globally