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

Thermo Fisher Scientific

Senior Staff Regulatory Affairs Specialist at Thermo Fisher Scientific ensuring compliance with global regulations and developing regulatory strategies for innovative products. Collaborating with cross-functional teams and maintaining compliance throughout product lifecycles.

Posted 4/23/2026full-timeRemote • 🇵🇹 PortugalSeniorWebsite

About the role

Key responsibilities & impact

Ensure compliance with global regulations
Interpret and disseminate global regulations, guidelines, and emerging industry developments
Work with cross-functional teams to bring innovative products to market
Develop and implement regulatory strategies
Maintain compliance throughout product lifecycles
Support continuous improvement of our regulatory tools and information systems

Requirements

What you’ll need

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

Benefits

Comp & perks

Standard work schedule (Mon-Fri)

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory affairsregulatory submissionsregulatory impact evaluationregulatory policiespost-market surveillanceregulatory information systemsemerging technologiesproject managementstrategic recommendationscompliance

Soft Skills

communication skillspresentation skillscollaborationstakeholder engagementcross-functional teamworkstrategic thinkingproblem-solvingadaptabilityleadershiporganizational skills

Certifications

advanced degreebachelor's degree