Consultant RA QA - ( Regulatory Affairs / Quality Assurance )

Consultant RA QA - ( Regulatory Affairs / Quality Assurance ) - Barcelona ( Hybrid )

We are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, regulatory strategy and QA services, among others, and we would love to speak with you if you have any of the skills or expertise in the quality & regulatory affairs and consulting domain.

About You – experience, education, skills, and accomplishments  

• Bachelor’s or master’s degree in pharmaceutical sciences
• At least 5 years of relevant work experience in quality affairs & regulatory affairs or in supporting quality & regulatory professional services/ Consulting projects.
• Quality Management System (QMS): set-up, maintenance, certification readiness.
• Impact/Gap assessment: review and implementation of changes related to new/updated legislation and standards.
• Process and organizational change management: workshop, SOP and workflow oriented.
• Audits: Performing and receiving audits from Certification Bodies in GxP and ISO QMS regulated systems.
• Inspections: Performing and receiving inspections from Competent Authorities (back-room and front-room).
• Project management: set-up and implementation of projects related primarily to RA, QA, Clinical affairs and Vigilance as well as implementation of related Enabling Technologies (platforms).
• Customer facing or customer service experience desirable.
• Demonstrated ability to learn on new domains, understand internal systems & processes and perform at the same time.

It would be great if you also had . . .  

• Exposure to regulatory consulting
• Master's degree in regulatory & quality affairs
• A flexible and collaborative approach to work
• Ability to prioritize effectively and adopt a systematic approach to tasks

What will you be doing in this role? 

Project Delivery Support (70%)

• Become an integral member of the delivery team within the Life Sciences Consulting group.
• Act as a point of contact for the customer throughout a project’s lifecycle.
• Act as the project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.

• Escalate any project risks and delivery issues to the Manager, Regulatory Services for action and resolution.
• Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.
• Deliver on routine projects, new development and one-off requests.

Business development (30%)

• Support to any received Requests for Information (RFIs) and Requests for Proposals (RFPs).
• Work with professional services colleagues to provide robust effort estimates for scoped projects.
• Support the creation of customer facing materials to support commercial discussions such as samples.
• The role will sometimes require you to work individually or as part of a team with knowledge sharing or as team player.

Projects you will be working on

• Quality Management System (QMS): set-up, maintenance, certification readiness
• Impact/Gap assessment: review and implementation of changes related to new/updated legislation and standards
• Process and organizational change management: workshop, SOP and workflow oriented
• Audits: Performing and receiving audits from Certification Bodies in GxP and ISO QMS regulated systems
• Inspections: Performing and receiving inspections from Competent Authorities (back-room and front-room)
• Project management: set-up and implementation of projects related primarily to RA, QA, Clinical affairs and Vigilance as well as implementation of related Enabling Technologies (platforms)

About the Team   

The team consists of six colleagues based in Barcelona and reporting to the Manager of Regulatory Solutions, as well as other colleagues in the US, India, and Europe. The Clinical and Regulatory Consulting Team works towards adding value to data from different sources and providing professional regulatory services to our global clients. The team works with internal databases like Cortellis intelligence, etc., and with external local consultants/ partners. The team here demonstrates good networking skills and establishes rapport with the client and