Principal Clinical Trial Regulatory Affairs, 4+ years in regulatory submissions

Syneos Health

Principal Clinical Trial Regulatory Affairs role at Syneos Health requiring 4+ years of regulatory submissions experience. Collaborate on regulatory strategies and manage customer relationships in clinical research.

Posted 7/18/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submissions and compliance within the US and Canada, with a strong focus on clinical research management and project profitability. Capable of mentoring and coaching team members while maintaining strategic relationships with clients.

Highest-signal resume keywords

Regulatory Submissions ExperienceClinical Research ManagementKnowledge of GxPsBudgeting and Quality ManagementExcellent Communication Skills

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

Regulatory FrameworksClinical Trial RegulationsMedical Device RegulationsDrug Development KnowledgeProject Management Procedures

Soft Skills

MentoringCoachingNegotiatingProblem-SolvingTeam-Oriented Approach

Industry Keywords

GVPGCPISO 14155Non-Interventional StudiesSite Activation Pathway

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
Participates in strategic development activities including account/ portfolio client meetings.
Line management responsibilities for staff members.
Develops and maintains strategic relationships with customers in alignment with their assigned projects.
Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables.
Prepares and communicates overall Regulatory strategy and status at client meetings.
Assumes accountability on the CTRA operations on specific project activities.
Reviews the project budget against project milestones and budget to ensure project profitability.

Requirements

What you’ll need

+4 years of experience in regulatory submissions in US/CAN
Bachelor’s Degree, Higher Degree Preferred.
Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non - interventional studies, clinical trial and medical device regulations)
Experience in working to applicable GxPs (e.g. GVP, GCP, ISO 14155) etc
Strong knowledge of clinical research management processes.
Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
Previous experience in budgeting and quality management
Ability to teach/mentor team members.
Ability to coach employees to reach performance objectives.
Excellent communication and interpersonal skills (both written and spoken) with an ability to influence, convince and persuade as well as a team-oriented approach.
Quality-driven in all managed activities
Strong negotiating and problem-solving skills.

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.