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Principal Advisory Consultant in Regulatory Affairs and Safety


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.

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 a principal advisory consultant with deep Regulatory Affairs and Safety expertise who wishes to make a mark in the digital transformation of the life science industry.

Are you driven by the opportunity to utilize your level of competences and experience to make a difference in multiple life science companies?
Then you are a perfect match for the role as our new advisory colleague.

Your responsibilities as a Regulatory Affairs Advisor
Working closely with clients, you will use your experience from Regulatory Affairs and 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 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.

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.

You will be part of NNIT’s Regulatory Affairs Advisory
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 advisory team is dedicated to leverage thought leadership knowledge with the newest technology, to shape business development and ensure highest quality across all implementation projects in close collaboration with the RA consultancy 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. The advisory team has key importance to the overall NNIT strategy.

Your qualifications and experiences
You may hold an MSc degree in life sciences or IT with significant experience from the life science industry, preferably Regulatory Affairs and/or Safety. You have a strong understanding of IT, and you manage to bridge your professional experience from the life science industry with IT. You must have a curious nature and interest in new technologies.

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.

We appreciate openness, honesty, and a winning attitude.

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 or Denmark

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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.

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