Senior Regulatory Affairs Study Start Up Specialist in United States Embassy at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Study Start Up Specialist based in United States.

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.
The position requires strong knowledge of clinical research regulations, documentation workflows, and country-specific requirements.
You will play a key role in accelerating clinical trial execution by maintaining regulatory readiness and operational excellence.
Working across multidisciplinary teams, you will help improve processes, support inspections, and ensure high-quality regulatory outcomes.
This is an opportunity for an experienced regulatory professional to contribute to advancing important medical research programs worldwide.

• 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.
• Advise clinical project teams, sponsors, and site personnel on regulatory requirements, submission strategies, and documentation expectations across different countries and regions.
• 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.
• Coordinate and oversee regulatory submissions, ensuring complete and accurate packages are prepared and submitted according to applicable timelines.
• 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.
• Provide regular regulatory status updates, participate in project meetings, and communicate risks, delays, and progress to stakeholders.
• Support continuous improvement initiatives by contributing to SOP updates, process enhancements, and training activities for regulatory teams.

• Associate’s or Bachelor’s degree in an allied health field such as nursing, pharmacy, health science, or equivalent relevant professional experience.
• 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.
• Strong organizational skills with the ability to manage multiple studies, priorities, and deadlines simultaneously.
• Excellent attention to detail with proven ability to identify inconsistencies, missing information, and quality issues.
• Strong written and verbal communication skills, with the ability to collaborate effectively with sponsors, sites, and cross-functional teams.
• 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.
• 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.

• Competitive compensation package.
• Opportunities for career advancement through mentoring programs and leadership development initiatives.
• Access to ongoing education, training programs, and tuition reimbursement opportunities.
• Flexible work arrangements, including hybrid and remote work options.
• Comprehensive health benefits and wellness support.
• Generous paid time off and vacation packages.
• Paid parental leave programs.
• Opportunity to contribute to innovative clinical research programs that help bring life-changing therapies to patients.
• Supportive, collaborative global work environment focused on professional growth and meaningful impact.