Regulatory Affairs Consultant
hace 2 semanas
About the Role
We are seeking a highly skilled Regulatory Affairs Consultant to join our Clinical and Regulatory Team at Clarivate. As a key member of our team, you will be responsible for delivering regulatory consulting projects and supporting business development initiatives.
Key Responsibilities
- Project Delivery Support (70%):
- Act as a point of contact for customers throughout a project's lifecycle.
- Manage regulatory professional services to ensure successful project delivery.
- Escalate project risks and delivery issues to the Manager of Regulatory Services.
- Support and deliver small pilot projects to validate understanding between proposed solutions and customer needs.
- Business Development (30%):
- Support Requests for Information (RFIs) and Requests for Proposals (RFPs).
- Collaborate with professional services colleagues to provide robust effort estimates for scoped projects.
- Contribute to the creation of customer-facing materials to support commercial discussions.
Projects You Will Be Working On
- Quality Management System (QMS) setup, maintenance, and certification readiness.
- Impact/Gap assessment and implementation of changes related to new/updated legislation and standards.
- Process and organizational change management, including workshops, SOPs, and workflow-oriented projects.
- Audits and inspections, including performing and receiving audits from Certification Bodies and Competent Authorities.
- Project management, including setup and implementation of projects related to RA, QA, Clinical affairs, and Vigilance, as well as Enabling Technologies.
About the Team
Our Clinical and Regulatory Consulting Team is a dynamic and collaborative group of professionals based in Barcelona and reporting to the Manager of Regulatory Solutions. We work with internal databases and external local consultants/partners to provide professional regulatory services to our global clients.
What We Can Offer You
- A modern culture environment combined with financial and stability advantages of working for a large business.
- Active volunteering community with 40 annual paid hours of volunteering time.
- Private Health and Life & Disability insurances.
- Tax-free benefits, including Ticket Restaurant scheme, kindergarten, and transport cards.
- Language classes (Catalan, Spanish, and English).
- Global and dynamic employee base (over 20 nationalities).
- 30 working days of vacation.
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
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