Regulatory Affairs and Quality Assurance Consultant
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 role presents an excellent opportunity to engage in regulatory and quality consulting initiatives. Our team possesses extensive expertise in data oversight, content development, and consulting across various sectors, including regulatory submissions, clinical studies, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC modifications, pharmacovigilance efforts, regulatory strategy, and quality assurance services. We invite you to connect with us if you have relevant skills or experience in the regulatory and quality consulting field.
About You – qualifications, experience, and skills
- A bachelor's or master's degree in pharmaceutical sciences.
- A minimum of 5 years of pertinent experience in quality and regulatory affairs or in providing quality and regulatory consulting services.
- Additional preferred qualifications include:
- Experience in regulatory consulting.
- A 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 division.
- Serve as the primary contact for clients throughout the duration of projects.
- Manage regulatory consulting projects to ensure successful execution, 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 ensure alignment between proposed solutions and 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 defined projects.
- Aid in the creation of client-facing materials to support commercial discussions.
- Occasionally work independently or as part of a team, fostering knowledge sharing.
Projects You Will Engage In
- Quality Management System (QMS): establishment, maintenance, and readiness for certification.
- Impact/Gap assessments: evaluation and implementation of changes related to new or updated regulations and standards.
- Process and organizational change management: workshops, standard operating procedures (SOPs), and workflow orientation.
- Audits: conducting and receiving audits from Certification Bodies in GxP and ISO QMS regulated environments.
- Inspections: conducting and receiving inspections from Competent Authorities.
- Project management: initiation and execution of projects primarily related to Regulatory Affairs, Quality Assurance, Clinical Affairs, and Vigilance, as well as the implementation of related enabling technologies.
About the Team
Our team comprises six professionals based in various locations, collaborating with colleagues in the US, India, and Europe. The Clinical and Regulatory Consulting Team is dedicated to enhancing data value from diverse sources and delivering professional regulatory services to our global clientele. We leverage internal databases and collaborate with external consultants and partners, demonstrating strong networking abilities and building rapport with clients and stakeholders.
Work Schedule
This is a permanent full-time position, typically requiring 40 hours per week, with a reduced schedule during the summer months. The working hours are flexible, primarily aligned with the CET time zone, with occasional adjustments for meetings with teams in other time zones.
What We Offer / Company Benefits
- A modern work culture combined with the stability and financial advantages of a large organization.
- An active volunteering community, providing 40 hours of paid volunteering time annually.
- Comprehensive private 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.
- 30 days of vacation per year.
At Clarivate, we are committed to providing equal employment opportunities for all individuals regarding hiring, compensation, promotion, training, and other employment conditions.
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