Global Clinical Regulatory Associate

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 aspires to be the leading Pan-American (ex-US) partner of choice, with a growing portfolio of innovative and high-quality branded products. The Global Clinical Regulatory Associate will enable this corporate ambition, by contributing directly or indirectly to its strategic priorities: in-licensing and developing new products across Pan-American markets (ex-US), achieving aggressive top line growth for promoted products and maximizing bottom line contribution across portfolio, and being an organization that acquires, develops, and retains critical talent.

The Global Clinical Regulatory Associate at Knight Therapeutics advises on clinical regulatory strategy by evaluating, interpreting, and integrating clinical information and study results provided by licensing partners, together with relevant published literature and other external evidence. The role supports regulatory submissions and lifecycle activities and coordinates with cross-functional colleagues (QA, Regulatory Affairs, Medical Affairs, and Commercial) and external partners to develop, assess, and maintain project timelines. This role does not involve sponsoring, designing, or conducting clinical studies on behalf of Knight.

Role Responsabilities:

• Support the preparation of pre-submission clinical regulatory packages.
• Work collaboratively with medical, regulatory, and commercial to support alignment on clinical regulatory strategy.
• Coordinate with vendors (medical writing, statistician, clinical pharmacology) for document preparation wherever applicable, tracking deliverables and timelines against agreed schedules.
• Contribute to clinical regulatory strategy by preparing evidence summaries, gap analyses, and background research based on clinical information and study documentation provided by licensing partners, supplemented by relevant published literature and other external sources.
• Develop and maintain working subject-matter knowledge of assigned products and therapeutic areas; respond to routine clinical regulatory questions form internal stakeholders and elevate complex or precedent-setting issues to the Senior Manager
• Support clinical regulatory lifecycle maintenance activities for assigned Knight products in those countries where Knight holds business.
• Review clinical data, study reports, and supporting information supplied by licensing partners, together with relevant published literature, and prepare evidence interpretations and summaries for regulatory interactions and submissions, for review by the Senior Manager.
• Review clinical development documentation and study outputs generated and provided by licensing partners, identify evidence gaps, and compile the relevant clinical components for regulatory submission dossiers.
• Assess and synthesize results from studies conducted or sponsored by licensing partners, as well as relevant evidence identified in the published literature, for inclusion in regulatory submission dossiers.
• Prepare clinical documentation and summaries for regulatory submissions and health authority interactions using partner-provided source documents, study results, and relevant published literature.
• Draft responses to clinical regulatory questions on dossiers under review based on partner-provided evidence, relevant published literature, and applicable regulatory guidance, for review and approval prior to submission.
• Conduct targeted literature reviews and external evidence searches to supplement information provided by licensing partners, support benefit-risk and clinical assessments, address evidence gaps, and draft responses to regulatory questions.
• Flag potential conflicts between clinical regulatory requirements, project timelines, and commercial objectives to the senior manager for resolution
• Maintain accurate documentation, trackers, and records of clinical regulatory activities in accordance with internal SOPs and applicable regulatory requirements
• concerns, marketing objectives, compliance, time to market, and regulatory costs.

Experience:

• 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) and good ability to interpret policies and guidelines.
• Prior experience working in a matrix organization
• Preferred: previous experience or training in biostatistics
• Languages: English (required); Spanish / Portuguese / French (required for local language based on location).
• Advanced scientific degree (i.e. M.Sc., Pharm.D., Ph.D., M.D) or M.S in life science from a reputable university or M.S in public health. Health Care professional preferred.
• Relative certifications on different Clinical Regulatory tools and databases will be considered