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Descripción del trabajo
We are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an excellent opportunity to work on regulatory consulting projects across various domains, including regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance, and regulatory strategy. We seek candidates with skills or experience in regulatory affairs and consulting.
About You – experiencia, educación, habilidades y logros
* Bachelor’s or master’s degree in pharmaceutical sciences
* At least 5 years of relevant experience in regulatory affairs or supporting regulatory consulting projects
* Experience in clinical trial data optimization, data management, MAA submissions
* Knowledge of Regulatory Intelligence, Pharmacovigilance, Clinical Trials, and registration processes
* Ability to learn new domains and internal systems efficiently
Desirable Skills
* Experience in regulatory consulting
* Master's degree in regulatory affairs
* Flexible, collaborative work approach
* Effective prioritization and systematic task management
Responsabilidades del rol
Project Delivery Support (70%)
* Integrate into the Life Sciences Consulting delivery team
* Serve as a contact point for clients during projects
* Manage regulatory projects ensuring successful delivery, coordination, and tracking
* Escalate risks and issues to the manager
* Support pilot projects and routine project execution
* Assist with RFIs and RFPs
* Provide effort estimates and customer-facing materials
* Work independently or collaboratively, sharing knowledge effectively
Projects
Various consulting projects including data monitoring, content creation, landscape analysis, newsletters, dashboards, guidance interpretation, and gap analysis for global clients in clinical and drug regulation.
Team Overview
The team of six, based in Barcelona with global colleagues, adds value through data analysis and regulatory services, using internal and external resources and fostering strong stakeholder relationships.
Working Hours
Full-time, 40 hours/week (35 hours in July-August), flexible schedule mainly CET, with occasional meetings outside regular hours. Hybrid work model with 2-3 days in the Barcelona office weekly.
Benefits
* Modern corporate culture with stability and growth opportunities
* Paid volunteering hours
* Private health, life, and disability insurance
* Tax-free benefits (meal vouchers, transport, childcare)
* Language classes
* International work environment with over 20 nationalities
* 30 days of vacation annually
LI-Hybrid, #LI-SK1
We are committed to equal employment opportunity and non-discrimination in all aspects of employment.
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