Principal Regulatory Affairs, Study Start Up Specialist

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

This role sits at the center of global clinical trial start-up and regulatory execution, ensuring studies are initiated efficiently, compliantly, and in alignment with country-specific and international requirements. You will oversee end-to-end regulatory submissions, ethics and competent authority interactions, and the preparation of essential study documentation across multiple regions. Acting as a key regulatory expert, you will guide cross-functional teams, sponsors, and sites through complex submission pathways while ensuring accuracy, consistency, and compliance at every step. The position also plays a critical role in study start-up strategy, including submission planning, document quality control, and readiness for regulatory “green light” approval. You will collaborate in a highly international environment, contributing to process improvements, mentoring regulatory staff, and supporting inspections and audits. This is a high-impact role for an experienced regulatory professional who thrives in structured, detail-driven, and global clinical research environments.

• Oversee preparation, coordination, and submission of core regulatory study documents across global and regional requirements.
• Develop and maintain regional and global regulatory submission plans in collaboration with project management teams and sponsors.
• Prepare, review, and adapt key study documents including Informed Consent Forms and submission packages.
• Coordinate with site teams to collect, validate, and resolve regulatory documentation for study start-up and green light readiness.
• Manage submissions to IRBs, IECs, and Competent Authorities, ensuring compliance with local and international regulations.
• Oversee EU/EEA submissions via CTIS, including Part I and Part II processes where applicable.
• Ensure accurate compilation, QC, and tracking of regulatory documents within eTMF and study start-up systems.
• Manage responses to regulatory queries, deficiency letters, and information requests in collaboration with internal and external stakeholders.
• Oversee translation of regulatory documents and coordination with external vendors when required.
• Ensure regulatory readiness for audits, inspections, and sponsor reviews, including documentation reconciliation and archiving.
• Provide guidance on regulatory requirements, import/export documentation, SUSAR submissions, and country-specific obligations.
• Lead, mentor, and support regulatory staff while contributing to training and process improvement initiatives.

Requirements

• Minimum 8 years of experience in regulatory affairs, clinical research, or related study start-up functions.
• Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Health Sciences, or equivalent relevant experience.
• Strong expertise in clinical trial submissions, ethics committee processes, and competent authority interactions.
• Experience with global clinical trial regulations, including EU/EEA requirements and CTIS submissions.
• Strong understanding of study start-up processes, regulatory documentation, and TMF/eTMF systems.
• Excellent organizational and project management skills with the ability to handle multiple priorities.
• High attention to detail and strong quality control mindset in regulatory documentation.
• Strong communication skills, with the ability to coordinate across global, cross-functional teams.
• Fluency in written and spoken English is required.
• Experience mentoring or leading teams and supporting regulatory training is highly desirable.
• Strong problem-solving, decision-making, and stakeholder management abilities.

Benefits

• Opportunity to work in a global clinical research organization with strong international exposure.
• Career development through structured mentoring and leadership growth opportunities.
• Involvement in high-impact clinical programs advancing treatments for serious and chronic conditions.
• Strong culture of collaboration, learning, and continuous improvement.
• Participation in global audits, inspections, and high-level regulatory initiatives.
• Access to training programs and professional development resources.