Associate Director, Regulatory Affairs – Clinical Trials (FSP Strategy & Business Development)

ThermoFisher Scientific; España; A distancia; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Staff Regulatory Affairs Specialist to interpret and disseminate global regulations while collaborating with cross-functional teams to bring innovative products to market.

You will contribute to regulatory strategies, maintain lifecycle compliance, and support improvements to regulatory tools, enabling patient safety and business growth on a global scale.

Formación

• Advanced degree plus 6+ years regulatory affairs experience or bachelor’s plus 8+ years.
• Deep knowledge of global regulatory requirements and emerging technologies.
• Proven track record in regulatory submissions and filings with global authorities.
• Experience managing regulatory information systems (RIMS).
• Strong communication and presentation skills for complex concepts.
• Advanced project management to handle multiple initiatives.
• Collaborative with stakeholders across functions in a global environment.

Responsabilidades

• Develop and implement regulatory strategies for products.
• Interpret global regulations and disseminate guidance to teams.
• Collaborate with cross-functional groups to bring products to market.
• Support post-market surveillance and vigilance activities.
• Maintain and improve regulatory information systems and tools.

Conocimientos

Regulatory strategy

Cross-functional

Regulatory submissions

RIMS experience

Regulatory communications

Project management

Stakeholder engagement

Global regulatory knowledge

Educación

Advanced degree in science/engineering/pharmacy

Bachelor's degree in science/engineering/pharmacy

Herramientas

Regulatory software tools

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our Regulatory Affairs team at Thermo Fisher Scientific, where you'll ensure compliance with global regulations. As a Senior Staff Regulatory Affairs Specialist, you'll interpret and disseminate global regulations, guidelines, and emerging industry developments while working with cross-functional teams to bring innovative products to market. You'll contribute to developing and implementing regulatory strategies, maintain compliance throughout product lifecycles, and support continuous improvement of our regulatory tools and information systems. This role offers the opportunity to make a meaningful impact by supporting patient safety while enabling business growth through effective regulatory compliance.

REQUIREMENTS:

• Advanced Degree plus 6 years of regulatory affairs experience, or Bachelor's Degree plus 8 years of regulatory affairs experience
• Preferred Fields of Study: science, engineering, pharmacy, or related field
• In-depth knowledge of global regulatory requirements and frameworks, particularly relating to emerging technologies
• Proven track record in regulatory submissions and filings with global authorities
• Strong ability to evaluate regulatory impact on products and provide strategic recommendations
• Experience managing and improving regulatory information systems (RIMS)
• Expert communication and presentation skills for conveying complex regulatory concepts
• Advanced project management capabilities to handle multiple complex initiatives
• Demonstrated ability to collaborate and engage with key stakeholders
• Experience liaising with regulatory authorities, trade associations, and professional bodies
• Proficiency with regulatory software tools and systems
• Ability to develop regulatory policies and guidelines
• Experience in post-market surveillance and vigilance activities
• Strong cross-functional collaboration skills
• Ability to work effectively in a global environment

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.