Manager RPR LATAM

CSL Plasma Inc.; Ciudad de México; Híbrido; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global biotherapeutics leader is seeking a Manager, Regulatory Partner Responsible (RPR) in Mexico City or Buenos Aires. The role involves partner management, oversight of partner activities, ensuring compliance with local regulatory standards, and developing strategies to optimize partner performance. Candidates should have at least 7 years of experience in governance or compliance roles within the healthcare industry and be fluent in Spanish and English. The position supports a hybrid work model and offers robust career opportunities.

Formación

• 7+ years of experience in oversight, governance, or compliance roles.
• Experience in pharmaceutical, biotechnology, or healthcare industry.
• Optional certifications in quality management and vendor management.

Responsabilidades

• Oversee key processes and ensure a framework for managing third-party activities.
• Perform due diligence and monitor partner performance against agreed metrics.
• Act as RA representative in audits and inspections.

Conocimientos

Fluency in Spanish

Fluency in English

Partner management

Regulatory compliance

Stakeholder management

Risk assessment

Training development

Auditing

Educación

Bachelor’s degree in relevant field

Master’s or PhD preferred

Descripción del empleo

Manager RPR GLAD & LATAM page is loaded

Overview

Role: Manager, Regulatory Partner Responsible (RPR) GLAD & LATAM. Location: Mexico City, Mexico or Buenos Aires, Argentina (hybrid onsite/remote). Reports to: Senior Manager, RA / PV Lead GLAD. Primary focus: partner management and oversight of partner activities with local partners, local industry associations, in-market commercial counterparts, and Regional Regulatory Lead (RRL) counterparts in the Global Regulatory Affairs (GRA) Regional team.

Responsibilities

• Strategy (execution) & partner management: oversee key processes and ensure a framework to manage third-party activities end-to-end with regulatory compliance and company standards.
• Perform due diligence, monitor partner performance against agreed metrics, address deviations promptly; conduct risk assessments of partners to identify risks and vulnerabilities.
• Manage partner inventory, identify and implement synergies; conduct periodic assessments and audits to ensure compliance with local requirements and quality standards; develop risk mitigation strategies and implement controls.
• Act as RA representative in audits/inspections; ensure readiness and timely CAPA closure in alignment with other functions.
• Serve as point of contact for escalations and issue resolution related to partner activities.
• Align with GRA for contract management to ensure regulatory standards are met; stay updated on local regulatory requirements and industry trends; participate in policy activities with industry groups and trade associations.
• Support regional regulatory TA teams within GRA for efficient planning and submission preparation according to local requirements.
• Act as primary RA representative for local ComOps: translate business perspective into actionable plans aligned with strategy.
• Keep RIMS up to date with local activity and ensure compliance KPIs are tracked.
• Internal stakeholder management and trainings; act as primary interface with local partners representing regulatory interests and ensuring appropriate interactions with health authorities.
• Work with Head Partner Business to oversee partner-specific activities for timely and standardized delivery of goods and services.
• Monitor training effectiveness and compliance; develop trainings as needed to address gaps and improve performance.
• Plan, lead and deliver complex regional strategies across CSL products, ensuring alignment with company and commercial strategies.

Qualifications

• Relevant Bachelor’s degree or equivalent in business administration, natural sciences (biology, chemistry or pharmacy), law or regulatory affairs; advanced degree (Master’s or PhD) preferred.
• Required fluency in Spanish and English, oral and written.
• 7+ years of experience in oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry.
• Optional but desired certifications in quality management and vendor management (e.g., CQA, CMQ, CSQP).
• Partner management experience: proven ability to manage relationships with third-party vendors (e.g., logistics providers, service providers).
• Experience managing commercial stakeholders, influencing key stakeholders, and applying a systematic approach to align with business needs.
• Ability to work in a highly matrixed organization and build cross-functional relationships across diverse disciplines and backgrounds.

About CSL Behring

CSL Behring is a global biotherapeutics leader focused on serving patients by discovering, developing and delivering therapies in immunology, hematology, cardiovascular/metabolic, respiratory, and transplant areas. We leverage plasma fractionation, recombinant protein technology, and cell and gene therapy platforms. CSL Behring operates CSL Plasma, a large global plasma collection network. Our parent company, CSL, is headquartered in Melbourne, Australia and employs 32,000 people in more than 100 countries.

Benefits & Equal Opportunity

For more information on CSL benefits, visit our site. CSL is an Equal Opportunity Employer. If you require a reasonable accommodation during the application process due to a disability, please contact us. Inclusion and Belonging is central to our culture.

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