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Regulatory Affairs Consultant
hace 2 meses
We are seeking a Regulatory Solutions Consultant to enhance our Clinical and Regulatory Team. This role presents a remarkable opportunity to engage in regulatory consulting initiatives. Our expertise spans 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 initiatives, and regulatory strategy, among others. We invite you to connect with us if you possess skills or knowledge in the regulatory affairs and consulting field.
About You – experience, education, skills, and accomplishments
- A bachelor's or master's degree in pharmaceutical sciences.
- A minimum of 5 years of pertinent experience in regulatory affairs or in supporting regulatory professional services/ consulting projects.
- Relevant experience in optimizing clinical trial data, managing clinical data, and MAA submissions.
- Regulatory Intelligence experience in pharmacovigilance, clinical trials, and new and post-approval registrations.
- Customer-facing or customer service experience is preferred.
- Proven ability to learn new domains, comprehend internal systems & processes, and perform concurrently.
It would be advantageous if you also had . . .
- Experience in regulatory consulting.
- A master's degree in regulatory affairs.
- A flexible and collaborative work style.
- Strong prioritization skills and a systematic approach to tasks.
What will you be doing 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.
- Act as the project manager for regulatory professional services to ensure successful project delivery, including coordination and tracking.
- Identify and escalate any project risks and delivery challenges to the Manager, Regulatory Services for resolution.
- Support and deliver small pilot projects to validate 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 any received 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.
- The role may require you to work independently or as part of a team, sharing knowledge and collaborating effectively.
Projects you will be working on
You will engage in various regulatory consulting projects, including data monitoring, content creation, regulatory landscape analysis, precedence studies, newsletters, custom dashboards, guidance interpretation, and gap analysis. The team serves global clients across multiple domains in the clinical and drug regulatory landscape for various product types.
About the Team
The team comprises six colleagues based in Barcelona, reporting to the Manager of Regulatory Solutions, alongside other colleagues in the US, India, and Europe. The Clinical and Regulatory Consulting Team is dedicated to enhancing data from diverse sources and delivering professional regulatory services to our global clientele. The team collaborates with internal databases and external local consultants/partners, demonstrating strong networking skills and building rapport with clients and stakeholders.
Hours of Work
This is a permanent full-time position with a standard workweek of 40 hours (35 hours during July and August). The working schedule is flexible, primarily aligned with the CET time zone, with occasional adjustments for meetings with US or East Asia time zones. The position allows for hybrid work, requiring attendance in the office a few times per week.
What We Can Offer You
- A modern cultural environment combined with the financial stability of a large organization.
- An active volunteering community, offering 40 paid hours annually for volunteering.
- Private health and life & disability insurance.
- Tax-free benefits, including a Ticket Restaurant scheme, kindergarten, and transport cards.
- Language classes in Catalan, Spanish, and English.
- A diverse and dynamic employee base, 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 terms and conditions.
