Jobgether

Senior Regulatory Affairs Study Start Up Specialist

US · Senior

Sponsorship not specifiedDetected 8 hours ago

ComplianceClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationMentoringOrganizational SkillsRegulatory Affairs

About the role

This role is responsible for managing critical regulatory documentation and supporting global clinical study start-up activities.
You will work closely with study teams, sponsors, sites, and regulatory bodies to ensure submissions are accurate, compliant, and delivered on time.
You will play a key role in accelerating clinical trial execution by maintaining regulatory readiness and operational excellence.

Independently manage essential regulatory documentation for global clinical studies, including submissions to Institutional Review Boards (IRBs), Ethics Committees (ECs), Competent Authorities (CAs), and other regulatory bodies.
Perform regulatory compliance assessments, identify documentation gaps, and communicate findings and recommendations to project leadership.
Review, adapt, compile, and quality-check study documents according to country-specific regulations, sponsor requirements, and internal procedures.
Manage communication with sites, clinical project teams, sponsors, and regulatory stakeholders to resolve document issues, clarification requests, and deficiencies.
Prepare, review, and maintain regulatory documents, including informed consent forms, clinical trial application forms, regulatory packages, and study start-up trackers.
Support drug release readiness activities by ensuring regulatory packages are complete and compliant with requirements.
Maintain accurate regulatory documentation within electronic or paper-based trial master file systems, following established naming conventions and quality standards.
Perform document reconciliation, close-out, archiving, audit preparation, and inspection readiness activities.
Support continuous improvement initiatives by contributing to SOP updates, process enhancements, and training activities for regulatory teams.

Minimum of 5 years of experience in pharmaceutical, clinical research site, or CRO regulatory affairs environments.
Strong understanding of clinical trial regulatory requirements, submission processes, and documentation standards.
Experience managing IRB/EC/CA submissions, regulatory packages, informed consent documentation, and study start-up activities.
Ability to interpret country-specific regulatory requirements and ensure compliance across multiple regions.
Excellent attention to detail with proven ability to identify inconsistencies, missing information, and quality issues.
Experience preparing for regulatory audits and inspections, including quality control and quality assurance activities.
Ability to work independently while contributing effectively within global, multidisciplinary teams.
The position requires strong knowledge of clinical research regulations, documentation workflows, and country-specific requirements.

Experience mentoring junior regulatory professionals and supporting team knowledge development is preferred.
Familiarity with clinical trial management systems, electronic Trial Master Files (eTMF), and regulatory tracking tools is a plus.

Access to ongoing education, training programs, and tuition reimbursement opportunities.
Comprehensive health benefits and wellness support.
Generous paid time off and vacation packages.
Paid parental leave programs.
Flexible work arrangements, including hybrid and remote work options.

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Advise clinical project teams, sponsors, and site personnel on regulatory requirements, submission strategies, and documentation expectations across different countries and regions.
Opportunities for career advancement through mentoring programs and leadership development initiatives.

Review, adapt, compile, and quality-check study documents according to country-specific regulations, sponsor requirements, and internal procedures

This listing is sourced directly from Jobgether's careers page and normalized into a canonical job model.