Pan-American Clinical Regulatory Specialist

Knight Therapeutics Argentina; Buenos Aires; Presencial; ARS 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

Knight Therapeutics Argentina seeks a Global Clinical Regulatory Associate to enable its Pan-American growth by advising on regulatory strategy and supporting submissions and lifecycle activities. You will collaborate with QA, Regulatory Affairs, Medical Affairs, and Commercial teams, coordinating with external partners to meet timelines.

The role focuses on evaluating clinical information, preparing evidence summaries, and ensuring regulatory alignment across markets.

Formación

• 3–5 years of experience in biotechnology/pharmaceutical industry.
• At least 1–2 years of experience in regulatory affairs or medical affairs.
• Experience in medical writing and clinical assessment.
• Knowledge of international regulations (ICH, EU and FDA).
• Experience in a matrix organization.
• English required; Spanish/Portuguese/French required for local language based on location.
• Advanced scientific degree (M.Sc., Pharm.D., Ph.D., M.D) or MS in life sciences.
• Certifications in Clinical Regulatory tools/databases welcome.

Responsabilidades

• Prepare pre-submission clinical regulatory packages.
• Collaborate with medical, regulatory, and commercial teams to align clinical regulatory strategy.
• Coordinate with vendors for document preparation and timelines.
• Develop evidence summaries, gap analyses, and background research for regulatory submissions.
• Maintain subject-matter knowledge of products and therapeutic areas; assist with regulatory questions.
• Support lifecycle maintenance for Knight products in relevant countries.
• Review regulatory documentation and identify evidence gaps for submissions.
• Assess study results and literature for inclusion in regulatory dossiers.
• Draft responses to regulatory questions based on evidence and guidelines.
• Conduct targeted literature reviews to support risk-benefit assessments.

Conocimientos

Regulatory affairs

Medical writing

Clinical assessment

Literature review

English proficiency

Biostatistics

Educación

Advanced degree

Descripción del empleo

Knight Therapeutics Argentina seeks a Global Clinical Regulatory Associate to enable its Pan-American growth by advising on regulatory strategy and supporting submissions and lifecycle activities. You will collaborate with QA, Regulatory Affairs, Medical Affairs, and Commercial teams, coordinating with external partners to meet timelines.

The role focuses on evaluating clinical information, preparing evidence summaries, and ensuring regulatory alignment across markets.