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Regulatory Affairs Consultant
hace 2 meses
We are seeking a Regulatory Solutions Consultant to become a vital part of our Clinical and Regulatory Team. This role presents an exceptional opportunity to engage in regulatory consulting initiatives. Our team possesses a robust skill set in data oversight, content development, and advisory services across various sectors, including regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, and regulatory strategy, among others. We invite you to connect with us if you have expertise in regulatory affairs and consulting.
About You – qualifications, experience, and skills
- Bachelor's or master's degree in pharmaceutical sciences.
- Minimum of 5 years of pertinent experience in regulatory affairs or in supporting regulatory professional services/consulting projects.
- Experience in optimizing clinical trial data, managing clinical data, and submitting MAAs.
- Knowledge in Regulatory Intelligence – including Pharmacovigilance, Clinical Trials, and both new and post-approval registrations.
- Experience in customer-facing roles or customer service is preferred.
- Proven ability to learn new domains, comprehend internal systems and processes, and perform effectively.
Additional Preferred Qualifications
- Familiarity with regulatory consulting.
- A master's degree in regulatory affairs.
- A flexible and collaborative work style.
- Strong prioritization skills and a systematic approach to tasks.
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.
- Support and execute small pilot projects to validate alignment between proposed solutions and client needs identified during the sales process.
- Deliver on routine projects, new developments, and one-off 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.
- The role may require independent work or collaboration as part of a team with knowledge sharing.
Projects Involved
Engage in various regulatory consulting projects, including data monitoring, content creation, regulatory landscape analysis, precedence assessments, 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 members based in Barcelona, reporting to the Manager of Regulatory Solutions, along 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. The team utilizes internal databases and collaborates with external consultants and partners, demonstrating strong networking abilities and establishing rapport with clients and stakeholders.
Work Schedule
This is a permanent full-time position, requiring 40 hours a week (35 hours during July and August). The working hours are 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, with in-office attendance in Barcelona 2-3 times per week.
Benefits Offered
- A modern work culture combined with the financial stability of a large organization.
- Active volunteering community, with 40 hours of paid volunteering time annually.
- Private health and life & disability insurance.
- Tax-free benefits, including a Ticket Restaurant scheme, kindergarten, and transport cards.
- Language classes (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.
