Principal Advisory Consultant in Regulatory Affairs

Vor 5 Tagen

Basel, Schweiz NNIT Vollzeit

_Use your experience to digitally transform Regulatory Affairs and Safety_

NNIT is 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. Experience with agile delivery such as SAFe is an advantage.

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.

NNIT was recently nominated as the most attractive workplace within the IT consulting area in Denmark.

**Your qualifications and experiences**

You may hold an MSc degree in Life sciences or IT with 3-5 years of experience from the life sciences 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 sciences 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.

Fluency in oral and written English is a must. Danish is beneficial.

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