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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.
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
- Contributing to business development and sales activities
- Contributing to and delivering 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 thought 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:
Essential requirements:
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- 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 recognized 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 Master’s level qualification in a relevant area of study such as Pharmaceutical Compliance or Regulation.
- Regulatory experience within the Pharmaceutical industry.
- Consulting experience within a recognized consulting firm.
- Experience working within Regulatory Affairs for a pharmaceutical company.
- Experience with Power BI application.
- Python coding and scripting experience.
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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, Spanish, 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 to taking this leading role in NNIT’s Regulatory Affairs team.
Apply now and make your mark!
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