Senior Consultant

NNIT; Follonica; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

NNIT is seeking a Senior Consultant in Regulatory Affairs to join our European regulatory team. You will own client engagements and drive regulatory projects, including IDMP data transformation, PMS/RIM integration, and RFP contributions. Expect a mix of consultancy delivery, business development, and mentoring junior staff.

Fluency in English is required; a second language (German, Danish, Italian, or French) is desirable. Travel up to 20% is expected as part of a multinational team.

Competenze

• Bachelor’s degree in Pharmaceutical Compliance or Regulation; relevant consulting/industry experience welcomed.
• Significant experience in Regulatory Affairs within Life Sciences/pharma.
• Experience in IDMP and related data transformation, PMS, and XEVMPD.
• Proven consulting experience, ideally in a large life sciences-focused firm.
• Familiarity with PMS, Postman API, and RIM systems is an asset.

Mansioni

• Own client engagements and manage specific Regulatory Affairs projects.
• Contribute to business development, presales and RFP delivery.
• Lead project delivery in advisory roles and mentor junior consultants.

Conoscenze

Regulatory Affairs

Consulting

Project leadership

Business development

Client relations

Documentation

Formazione

Bachelor’s degree in Pharmaceutical Compliance or Regulation

Masters degree (preferred)

Strumenti

Power BI

Postman API

RIM systems

Python scripting

Descrizione del lavoro

UK, Denmark, Italy, Germany, Poland, Czech, Ireland, Switzerland

Type of contract: Permanent
Location(s): UK, Denmark, Italy, Germany, Poland, Czech, Ireland, Switzerland
Language(s): English
Mobility: Some Travel
Application Deadline: 30/10/2026

Senior Consultant - Regulatory Affairs

NNIT is one of the world’s leading consultancies for the past twenty years serving the Life Science industry around the world. We strive to enable our customers to achieve their business goals through digitalization within Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes.

Your Responsibilities

You will join our Regulatory Affairs team as a Senior Consultant. You will contribute to forming a variety of tasks and functional responsibilities within the Regulatory Affairs business unit such as taking ownership of client engagements and specific projects, contribute to business development and sales activities and contribute to and deliver Requests for Proposal (RFP’s) as required.

On Average You Will Split Your Time

• 75% delivering in consultancy projects in advisor, project lead or architect roles, and acting as engagement delivery lead.
• 10% in business development, presales and though leadership activities
• 10% in the development and delivery of RFP’s to ensure NNIT successfully engages new and additional projects
• 5% in coaching and mentoring of more junior consultants in the Regulatory Affairs team

Essential Requirements

Your qualifications and experience:

• A Bachelor’s Degree (or similar) in a field related to Pharmaceutical Compliance or Regulation. Other relevant academic qualifications can be considered if you also have highly significant consulting and/or industry based experience in
• Regulatory Affairs within Life Sciences.
• Significant experience in Regulatory Affairs within a Pharmaceutical company or as a consultant.
• Proven consulting based experience is an essential requirement for the role, ideally within a large recognised consultancy with a life sciences division or specialism.
• A proven level of experience in the area of IDMP including some of the following:
• Experience in IDMP data transformation
• Data enrichment for PMS, RIMS and XEVMPD
• Experience with RIM systems related to IDMP
• Fully aware and cognizant of current EMA updates on IDMP
• Experience presenting IDMP topics to larger audiences
• Proficiency in PMS and Postman API
• Experience in managing interactions with clients, partners and vendors and an interest in driving and expanding NNIT client relations as part of business development, pre-sales and project delivery activities.
• First class documentation, communication, and interpersonal skills, with an ability to liaise effectively and professionally with individuals at all levels.

Preferred Requirements

• A Masters level qualification in a relevant area of study such as Pharmaceutical Compliance or Regulation.
• Regulatory experience within the Pharmaceutical industry.
• Consulting experience within a recognised consulting firm.
• Experience working within Regulatory Affairs for a pharmaceutical company.
• Experience with Power BI application.
• Phyton coding and scripting experience.

Why should you join NNIT & What we offer to you?

• A dynamic workplace with good working conditions, social activities, team events and work life balance.
• Opportunity to work in a multicultural company with a friendly and dynamic work environment.
• Competitive salary, additional bonus and benefit package (contribution to your home internet, fitness funding, and others).
• An Informal and friendly working culture between NNIT colleagues.
• Opportunity to work with the most significant life sciences clients.
• Diversity of projects, and the possibility of shaping your own career path.
• Personal development model which defines your long-term career goals.

We are hiring into our European team in the following countries: UK or Europe

Fluency in oral and written English is a must. A second language (German, Danish, Italian or French) is desired but not essential.

Travel must beexpected, but will be kept to necessary business trips (<20%).

About NNIT

NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers.

NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,600 people in Europe, Asia, and USA.

We celebrate diversity and are dedicated to fostering an inclusive environment for all employees. We actively work to eliminate bias and ensure an inclusive workplace where everyone has the right to be seen and heard as they are. We invite interested candidates to apply, no matter their background.

In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.