Regulatory Affairs Lead- FSP

Thermo Fisher Scientific; Sevilla; Presencial; EUR 50.000 - 100.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Regulatory Affairs Lead to join their expanding Global Regulatory Affairs team. This pivotal role involves supporting clinical trials and providing strategic guidance across multiple countries while ensuring compliance with global regulatory standards. The ideal candidate will have substantial experience in regulatory affairs with a focus on EU Clinical Trial Regulation, and will take on responsibilities including document preparation, mentorship of junior staff, and client engagement.

Servicios

Competitive salary

Extensive benefits

Flexible work culture

Collaborative environment

Formación

• 8+ years of relevant experience in Regulatory Affairs.
• Deep understanding of global regulatory requirements, especially EU Clinical Trial Regulation.
• Strong organizational skills with an emphasis on regulatory documentation.

Responsabilidades

• Overseeing multiple countries/projects, providing regulatory intelligence and guidance.
• Preparing regulatory documents and ensuring compliance with standards.
• Leading and mentoring junior team members on regulatory assessments.

Conocimientos

Excellent English communication skills

Attention to detail

Strong interpersonal abilities

Proficiency in Microsoft Office

Analytical and problem-solving skills

Educación

Bachelor's degree or equivalent

Descripción del empleo

Join to apply for the Regulatory Affairs Lead- FSP role at Thermo Fisher Scientific .

Get AI-powered advice on this job and more exclusive features.

Work Schedule : Standard (Mon-Fri)

Environmental Conditions : Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with resources to achieve career goals and push scientific boundaries through research, development, and delivery of life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services across over 100 countries, aiming to improve health outcomes worldwide.

Our expanding Global Regulatory Affairs team is seeking a Regulatory Affairs Lead for a client-dedicated role. This position involves supporting clinical trial indications from early to late development, with a focus on EU CTR experience and global regulatory knowledge.

The Reg Affairs Lead will oversee multiple countries / projects, providing strategic regulatory intelligence and guidance to support product development from preclinical stages through registration and optimization. Responsibilities include preparing regulatory documents, ensuring compliance with regional and international standards, and liaising with clients and internal teams.

Essential Functions :

• Senior review of regulatory documents and submissions to ensure quality and compliance.
• Providing regulatory strategy advice and updates on legislation to clients and internal teams.
• Supporting project management activities and client engagement for regulatory services.
• Leading and mentoring junior team members on regulations and study assessments.
• Contributing to performance reviews, project budgets, and scope management.
• Ensuring adherence to SOPs and contributing to business development activities.

Qualifications :

Education and Experience :

• Bachelor's degree or equivalent, with 8+ years of relevant experience.
• Equivalent combinations of education, training, and experience may be considered.

Knowledge, Skills, and Abilities :

• Excellent English communication skills; local language proficiency where applicable.
• Attention to detail, editorial skills, and strong interpersonal abilities.
• Proficiency in Microsoft Office and ability to learn new technologies.
• Strong organizational, negotiation, and independent judgment skills.
• Deep understanding of global / regional / national regulatory requirements, especially EU Clinical Trial Regulation and clinical trial applications.
• Experience in global CTAs is advantageous.
• Knowledge of medical terminology, statistical concepts, and regulatory guidelines.
• Analytical, problem-solving, and budgeting skills.

What we offer : Competitive salary, extensive benefits, flexible work culture, and a collaborative environment committed to innovation and impact. Join us to help make the world healthier, cleaner, and safer. #StartYourStory with PPD, part of Thermo Fisher Scientific.

Apply today at

Thermo Fisher Scientific is an Equal Opportunity Employer, valuing diversity and inclusion.

J-18808-Ljbffr

J-18808-Ljbffr