Senior Regulatory Affairs Consultant - Life Sciences & IDMP

Nnit A/S; Polska; On-site; PLN 180,000 - 290,000; Full time

Benefits offered by this job

Competitive salary

Bonus and benefits

Home internet contribution

Fitness funding

Social activities

Job summary

NNIT seeks a Senior Consultant to join our Regulatory Affairs team. You will own client engagements and lead projects, contribute to business development and bid responses, and help deliver RFPs. You will also coach junior consultants and work with cross-functional teams across Europe.

The role requires substantial IDMP experience, PMS/XEVMPD familiarity, and proficiency with Power BI, Postman API, and RIM systems. Travel up to 20% is expected.

Qualifications

• Bachelor's degree in Pharmaceutical Compliance or Regulation required.
• Significant Regulatory Affairs experience in life sciences.
• Consulting experience in a recognised firm preferred.
• Experience with IDMP and related data transformation is essential.
• Familiarity with PMS, XEVMPD, and RIM systems is desirable.

Responsibilities

• Owner of client engagements and specific projects within Regulatory Affairs.
• Contribute to business development and pre-sales activities.
• Deliver RFP responses and support project delivery.
• Coach and mentor junior consultants in the team.

Skills

Regulatory Affairs

IDMP

PMS

RIMS

XEVMPD

Postman API

Power BI

Python

Education

Bachelor's degree in Pharmaceutical Compliance or Regulation

Master's degree in Pharmaceutical Compliance or Regulation

Tools

Power BI

Postman API

Python

RIM systems

IDMP data transformation

Job description

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.

To further strengthen our Regulatory Affairs team, we are looking for a Senior Consultant with a diverse skill set across Regulatory Affairs in the life sciences industry including some IDMP regulatory affairs exposure.

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.

• 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

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 be expected, but will be kept to necessary business trips (<20%).

What’s next?

If you recognize yourself in this role, we’ll be looking forward to hearing from you. Please apply with a full resume and references that describe your abilities with regard of taking this leading role in NNIT’s Regulatory Affairs team.