Quality and Regulatory Affairs Specialist
hace 4 semanas
We are seeking a Regulatory Affairs and Quality Assurance Consultant to join 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 and Skills
- Bachelor's or master's degree in pharmaceutical sciences.
- A minimum of 5 years of relevant experience in quality affairs and regulatory affairs or in supporting quality and regulatory consulting projects.
- Preferred Qualifications:
- Experience in regulatory consulting.
- Master’s degree in regulatory and quality affairs.
- Customer-facing or customer service experience.
Responsibilities in this Role
Project Delivery Support (70%)
- Become a vital 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 project risks and delivery challenges to the Manager of Regulatory Services for resolution.
- Support and execute small pilot projects to align proposed solutions with client needs identified during the sales process.
- Deliver routine projects, new developments, and ad-hoc 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 the creation of client-facing materials to support commercial discussions.
- Occasionally work independently or as part of a team, sharing knowledge effectively.
Projects You Will Engage In
- Quality Management System (QMS): setup, maintenance, and certification readiness.
- Impact/Gap assessment: review and implement changes related to new or updated legislation and standards.
- Process and organizational change management: workshops, SOPs, and workflow-oriented tasks.
- Audits: conduct and receive audits from Certification Bodies in GxP and ISO QMS regulated systems.
- Inspections: conduct and receive inspections from Competent Authorities.
- Project management: setup and implementation of projects primarily related to RA, QA, Clinical affairs, and Vigilance, including related Enabling Technologies.
About the Team
Our team consists of six professionals based in various locations, collaborating with colleagues globally. The Clinical and Regulatory Consulting Team focuses on enhancing data value from diverse sources and delivering professional regulatory services to our international clients. We leverage internal databases and collaborate 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 flexible working schedule primarily aligned with CET time zone, occasionally accommodating meetings with other time zones.
Company Benefits
- A modern cultural environment combined with the stability of a large organization.
- Active volunteering community, offering 40 annual paid hours for volunteering.
- Private health and life & disability insurance.
- Tax-free benefits including meal vouchers and transportation cards.
- Language classes available (Catalan, Spanish, and English).
- A diverse employee base with over 20 nationalities.
- 30 working days of vacation.
At Clarivate, we are dedicated to providing equal employment opportunities for all individuals regarding hiring, compensation, promotion, training, and other employment conditions.
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