Consultant in Regulatory and Quality Assurance
hace 4 semanas
We are seeking a Regulatory Affairs and Quality Assurance Consultant to become a vital part of our Clinical and Regulatory Team. This is an exceptional opportunity to engage in regulatory and quality consulting initiatives. Our team possesses a robust skill set in data oversight, content development, and consulting across various sectors, including regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, regulatory strategy, and quality assurance services. We invite you to connect with us if you have expertise in quality and regulatory affairs and consulting.
About You – qualifications, experience, and skills
- Bachelor's or master's degree in pharmaceutical sciences.
- Minimum of 5 years of relevant experience in quality affairs and regulatory affairs or in providing quality and regulatory professional services/consulting projects.
- Preferred qualifications include:
- Experience in regulatory consulting.
- Master's degree in regulatory and quality affairs.
- Experience in customer-facing roles or customer service.
Responsibilities in this role:
Project Delivery Support (70%)
- Become an essential member of the delivery team within the Life Sciences Consulting group.
- Serve as the primary contact for clients throughout the project lifecycle.
- Manage regulatory professional services projects to ensure successful delivery, including coordination and tracking.
- Identify and escalate any project risks and delivery challenges to the Manager of Regulatory Services for resolution.
- Assist in delivering small pilot projects to align proposed solutions with client needs identified during the sales process.
- Execute routine projects, new developments, and unique requests.
Business Development (30%)
- Assist with Requests for Information (RFIs) and Requests for Proposals (RFPs).
- Collaborate with professional services colleagues to provide accurate effort estimates for scoped projects.
- Aid in creating customer-facing materials to support commercial discussions.
- Occasionally work independently or as part of a team, sharing knowledge and expertise.
Projects You Will Engage In
- Quality Management System (QMS): establishment, maintenance, and certification readiness.
- Impact/Gap assessments: reviewing and implementing changes related to new or updated legislation and standards.
- Process and organizational change management: workshops, SOPs, and workflow-oriented tasks.
- Audits: conducting and receiving audits from Certification Bodies in GxP and ISO QMS regulated systems.
- Inspections: conducting and receiving inspections from Competent Authorities.
- Project management: setting up and implementing projects primarily related to RA, QA, Clinical affairs, and Vigilance, along with related enabling technologies.
About the Team
Our team comprises six professionals based in various locations, collaborating with colleagues across the globe. The Clinical and Regulatory Consulting Team focuses on adding value to data from diverse sources and delivering professional regulatory services to our international clients. The team effectively utilizes internal databases and collaborates with external consultants and partners, demonstrating strong networking skills and building rapport with clients and stakeholders.
Work Hours
This is a permanent full-time position with a standard workweek of 40 hours (35 hours during summer months). The working schedule is flexible, primarily aligned with CET time zone, with occasional adjustments for meetings with clients in different time zones.
Company Benefits
- A modern work culture combined with the stability and advantages of a large organization.
- Active volunteering community, offering 40 hours of paid volunteering time annually.
- Comprehensive health and life insurance coverage.
- Tax-free benefits including meal vouchers and transportation cards.
- Language classes available (Catalan, Spanish, and English).
- A diverse and dynamic workforce representing over 20 nationalities.
- Generous vacation policy with 30 working days off.
At Clarivate, we are dedicated to providing equal employment opportunities for all individuals regarding hiring, compensation, promotion, training, and other employment conditions. We adhere to applicable laws and regulations governing non-discrimination in all locations.
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