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Regulatory Affairs Consultant


Regulatory Affairs Consultant

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.

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

We are looking for Regulatory Affairs consultants with deep pharmaceutical expertise and regulatory insight who wishes to make a mark in the digital transformation of the life science industry.

Are you driven by leveraging your skillset with digital acumen, having responsibility and ownership of projects, and do you want to change the life science industry?
Then you are a perfect match for the role as our new RA colleague.

Your responsibilities as a Regulatory Affairs Consultant
You will join an exciting, international department with highly skilled colleagues that have a deep understanding of the industry and the ability to bridge this knowledge with digital technologies and deliver the highest quality implementations.

Working closely with clients, you will use your experience from Regulatory Affairs to assist companies in a vast array of projects, spanning from process optimization to new digital tools implementation.

You will be expected to support clients on implementing 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.

Your career will include continuous training and competence development to support our department and your personal ambitions.

You will be part of NNIT’s Regulatory Affairs Consulting
NNIT Regulatory Affairs is at the forefront of supporting global pharmaceutical and medical device clients on the latest digital trends within Regulatory Affairs and Safety.

Our commitment to the life science industry is reinforced in our devotion to the advisory and consultancy unit. This makes us stand out, is key to our costumer success and emphasize our leadership position in RA consulting.

The specialized RA consultancy team is dedicated to leverage RA knowledge with the newest technology, to ensure highest quality across implementation projects in close collaboration with the RA Advisory team.

We are an ambitious department with highly skilled colleagues with deep understanding of the industry. We are a diverse mix of nationalities with different educational backgrounds and an even mix of gender.

Your qualifications and experiences
You may hold an MSc degree in life sciences or IT with solid 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 with IT and build solid implementations with the costumer in focus.
Experience with agile delivery such as SAFe is an advantage.

It is an advantage if you have experience with Regulatory business processes and how digitalization can support business process efficiency. You know that a winning personality will help you build trust and enable great customer engagement, and you might have gained this experience from a past job within the consulting area.

We appreciate openness, honesty, and a winning attitude.
We expect that you are quickly integrating with customers and internal teams and that the customer satisfaction will be key to your personal success.

NNIT has offices in Copenhagen, Frankfurt, and Basel, and you might live in the proximity of these pharma hubs.
Fluency in oral and written English is a must. German, French and/or Danish is beneficial.
Depending on your location and specific project responsibilities, 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.

  • Rated as Leading RA Consultancy by GENS & ASSOCIATES
  • Rated as most Responsible and Trustworthy IT consultancy house with Highest Quality and Best Implementation Skills by MyResearch in DK
  • First Veeva Premiere Services Partner
  • 100+ RA dedicated consultants in DK, CH, DE, CN, US
  • 30+ Current RA clients, incl. several tier 1 pharma clients

3000+ Employees in NNIT globally

Location: Germany, Switzerland and Denmark

Application deadline: 30 Sep 2021

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Ansøgningsfrist d. 30.09.2021
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NNIT A/S - hurtigt overblik

IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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