Overview
In this role you will join NNIT’s Regulatory Affairs team to lead engagements and deliver regulatory projects for life sciences clients. You will balance consultancy delivery, business development, and bid activities, while mentoring junior consultants. The position emphasizes IDMP experience and client-facing delivery in a dynamic, cross-European environment. You will work with major life sciences clients to shape regulatory strategies and ensure compliant digital solutions.
Leistungen / Benefits
- dynamic workplace and social activities
- multicultural environment
- competitive salary and bonus/benefits package
- informal and friendly culture
- opportunity to work with major life sciences clients
- career development and diverse project portfolio
Verantwortungsbereiche
- Own client engagements and specific regulatory projects
- Contribute to business development and sales activities
- Prepare and deliver RFPs to win new projects
- Deliver consultancy projects in advisor, project lead, or architect roles
- Act as engagement delivery lead
- Coach and mentor junior consultants in Regulatory Affairs
- Support cross-functional collaboration within NNIT and with clients
- Travel up to <20>
Zentrale Anforderungen
- Bachelor’s Degree in Pharmaceutical Compliance or Regulation (or similar)
- Significant Regulatory Affairs experience in pharma, in-house or consulting
- Proven consulting experience, ideally with a life sciences division of a large firm
- Experience with IDMP (data transformation, data enrichment for PMS/RIMS/XEVMPD, RIM systems)
- Awareness of EMA updates on IDMP and ability to present IDMP topics to audiences
- Proficiency with PMS and Postman API
- Strong client, partner, and vendor management and business development interest
- First-class communication and interpersonal skills
- Strong communication and presentation skills
- Client relationship management
- Leadership and mentoring abilities
- IDMP data transformation
- Data enrichment for PMS, RIMS, XEVMPD
- RIM systems related to IDMP
