Regulatory Affairs Lead- FSP

Thermo Fisher Scientific; Valladolid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading company in life sciences is seeking a Regulatory Affairs Lead to support clinical trials and ensure compliance with EU regulations. This role involves strategic oversight of regulatory submissions and mentoring junior staff, contributing to impactful health outcomes globally.

Servicios

Competitive salary

Extensive benefits

Flexible work culture

Collaborative environment

Formación

• 8+ years of relevant experience in regulatory affairs.
• Strong understanding of EU Clinical Trial Regulation.
• Experience in global CTAs is advantageous.

Responsabilidades

• Oversee regulatory documents and ensure compliance.
• Provide regulatory strategy advice to clients.
• Lead and mentor junior team members.

Conocimientos

Attention to detail

Communication

Negotiation

Analytical skills

Educación

Bachelor's degree or equivalent

Herramientas

Microsoft Office

Descripción del empleo

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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.

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