Senior Regulatory Affairs Study Start Up Specialist

• 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.

Requirements:

• 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.

Benefits:

• 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.