Regulatory Affairs Manager - Regulatory Liaison - FSP

• Work Schedule Standard (Mon-Fri)
• Environmental Conditions Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

Within our Functional Service Provider (FSP) Solutions business, we partner with leading pharmaceutical, biotechnology, and medical device organizations by providing dedicated regulatory professionals integrated within client teams.

The Regulatory Liaison serves as the primary regulatory representative supporting global clinical development programs.

This role acts as the key interface between Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to ensure timely, compliant regulatory submissions and effective execution of clinical trial activities.

The position supports regulatory strategy through operational excellence while ensuring compliance with global and local regulatory requirements.

• # Key Responsibilities
• Serve as the primary regulatory representative within assigned clinical trial teams.
• Coordinate and manage regulatory activities supporting global clinical development programs.
• Prepare, review, compile, and coordinate regulatory submission packages, including:
• Clinical Trial Applications (CTAs)
• Substantial Amendments
• Investigator's Brochures (IBs)
• Investigational Medicinal Product Dossiers (IMPDs)
• Country-specific regulatory documentation
• Ensure submissions are completed accurately and within established timelines in accordance with applicable regional regulations, including EU Clinical Trial Regulation (CTR), ICH-GCP, FDA, MHRA, Health Canada, and other global requirements as applicable.
• Act as the primary point of contact for regulatory operational activities between Thermo Fisher Scientific, assigned client teams, CRO partners, and regulatory vendors.
• Track regulatory milestones and submission status while maintaining oversight of regulatory deliverables.
• Maintain complete and inspection-ready regulatory documentation throughout the clinical trial lifecycle.
• Ensure compliance with applicable regulatory requirements, client procedures, and Thermo Fisher Scientific quality standards and SOPs.
• Collaborate with Clinical Operations, Medical Affairs, Regulatory Strategy, Start-Up, Document Management, and other cross-functional teams to support efficient trial execution.
• Support transparency and disclosure activities where applicable.
• Identify opportunities for process improvements, operational efficiencies, and regulatory best practices.
• Provide guidance and mentorship to junior regulatory team members when appropriate.
• Participate in client governance meetings and contribute to continuous improvement initiatives within the FSP organization.
• # Required Skills & Competencies
• ### Regulatory Expertise
• Strong understanding of global clinical trial regulations, including:
• EU Clinical Trial Regulation (EU CTR 536/2014)
• ICH Guidelines
• FDA regulations
• Other regional regulatory frameworks
• Knowledge of clinical trial start-up and lifecycle regulatory requirements.
• ### Project Management
• Strong organizational and planning skills.
• Ability to manage multiple studies and competing priorities.
• Demonstrated ability to work under tight timelines while maintaining high-quality deliverables.
• Excellent attention to detail.
• ### Analytical Skills
• Ability to interpret complex regulatory requirements and translate them into operational activities.
• Strong problem-solving and critical-thinking abilities.
• Ability to summarize regulatory information and prepare concise documentation.
• ### Technical Skills

- Experience with

• Electronic regulatory submission systems
• Clinical Trial Management Systems (CTMS)
• Electronic Document Management Systems (e TMF/EDMS)
• Microsoft Office Suite
• ### Communication
• Excellent written and verbal communication skills.
• Ability to build collaborative relationships across global, cross-functional teams.
• Strong stakeholder management and influencing skills.
• Fluent English required; additional languages are advantageous.
• ### Professional Attributes
• Highly collaborative with a customer-focused mindset.
• Demonstrates accountability and ownership.
• Adaptable within changing project environments.
• Able to work independently while contributing effectively within matrix organizations.
• Committed to quality, compliance, and continuous improvement.
• # Education & Experience
• ### Required
• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline.
• Advanced degree (Master's or equivalent) preferred.
• Minimum 5 years of pharmaceutical, biotechnology, CRO, or clinical research experience.
• Minimum 3 years of experience in Regulatory Affairs supporting clinical trials.
• Experience preparing and coordinating global regulatory submissions.
• Experience working within cross-functional global project teams.
• ### Preferred
• Experience supporting Functional Service Provider (FSP) or outsourced regulatory delivery models.
• Experience working in global, multi-country clinical development programs.
• Knowledge of Clinical Trial Information System (CTIS).
• Experience supporting regulatory inspections or audits.

# Why Join Thermo Fisher Scientific?

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell.

Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

As part of our FSP Solutions team, you will

• Work alongside leading global pharmaceutical and biotechnology organizations.
• Build expertise across diverse therapeutic areas and regulatory environments.
• Benefit from continuous learning and career development opportunities.
• Be part of an inclusive, collaborative, and innovative culture dedicated to scientific excellence.

Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive workplace where everyone can thrive