Regulatory affairs officer – São Paulo/SP

Responsabilidades

• Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.
• Draft, review, and quality-check clinical trial regulatory core study documentation at global and country level.
• Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback.
• Engage with Competent Authorities in countries across multiple regions, as part of the clinical trial regulatory strategy for complex global studies.
• Monitor scope, deliverables, timelines, and budget; proactively mitigate risks and escalate issues as needed.
• Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.
• Contribute to internal SOP reviews and present regulatory processes at full-service bid defenses.
• Perform additional tasks assigned by Regulatory management to meet program goals.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor’s or Master’s degree in Life Sciences or related discipline.
  • 3–4 years of relevant clinical trial regulatory experience within CRO or biotech/pharma.
  • Strong understanding of the R&D continuum (CMC, preclinical, clinical) and applicable laws, guidelines, and agency expectations for clinical trials.
  • Demonstrated expertise in at least one clinical trial regulatory domain (e.g., CMC, labeling).
  • Experience with clinical trial regulatory submission platforms and pathways, including but not limited to, EU CTR, Health Canada, US FDA IND submissions and/or systems in other regions such as LATAM or APAC.
  • Proficiency with Microsoft Office and regulatory publishing tools (e.g., eCTD systems); meticulous document management skills.
  • Excellent written and verbal communication, organization, and stakeholder-management abilities.
  • Proven ability to manage multiple projects; work in a fast-paced environment with competing priorities; and view obstacles as challenges to be handled with ease and grace; follow SOPs consistently, and exercise sound judgment on discrete tasks.
  • Problem-solving mindset with adaptability in fast-changing environments; self-motivated and collaborative.
• QUALIFICAÇÕES PREFERENCIAIS
  • Biotech therapy area exposure welcomed.

Marcado como: Assuntos Regulatórios, Documentação, Gestão de Projetos, Indústria Farmacêutica, Pesquisa Clínica