Manager Rpr Glad & Latam

Csl Plasma; Xico; Híbrido; MXN 600,000 - 800,000; Jornada completa

Descripción de la vacante

A global biopharmaceutical company is seeking a Manager, RA / PV Lead to oversee partner management in Latin America. This role involves ensuring compliance with regulations, conducting risk assessments, and fostering relationships with local partners. The ideal candidate holds a relevant Bachelor's degree and has over 7 years of experience in the pharmaceutical sector. Fluency in both Spanish and English is required for effective communication with international colleagues. The position supports both onsite and hybrid work arrangements.

Formación

• 7+ years of experience in oversight, governance, or compliance roles within pharmaceutical or healthcare industry.
• Experience managing relationships with third-party vendors and influencing commercial stakeholders.
• Ability to work in a highly matrixed organization.

Responsabilidades

• Ensure oversight on key processes and compliance with regulations.
• Conduct risk assessments of partners and manage inventory of partners.
• Act as point of contact for escalations and issue resolution related to partner activities.

Conocimientos

Fluency in Spanish and English

Partner management

Regulatory compliance

Relationship management

Educación

Relevant Bachelor's degree

Advanced degree (Master's or PhD)

Descripción del empleo

The OpportunityReporting to the Sr.

Role Overview

Manager, RA / PV Lead GLAD, as the Manager, RPR (Regulatory Partner Responsible) GLAD (Group of Latin American Distributors) LATAM, your primary responsibility will be to focus on partner management and oversight of partner activities.

Key Interactions

Your key interactions will be with local partners, local industry association(s), in‑market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA (Global Regulatory Affairs) Regional team.

Location & Work Arrangement

This role can be based out of our Mexico City, Mexico or Buenos Aires, Argentina sales affiliate offices. This is a hybrid role, which offers a combination of an onsite and remote work schedule.

Responsibilities

Strategy (execution) & (partner) management. Ensure oversight on key processes and ensure framework is in place to manage third‑party activities E2E ensuring compliance with regulations and company standards; perform due diligence, monitor partner performance against agreed‑upon metrics and standards, addressing any deviations or deficiencies promptly; conduct risk assessments of partners to identify potential risks and vulnerabilities. Manage inventory of partners and ensure synergies are identified and implemented. Conduct periodic assessments and audits of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions. Act as point of contact for escalations and issue resolution related to partner activities. Align closely with GRA for contract management purposes to ensure regulatory standards are met. Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating 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 and business needs. Act as primary RA representative for local ComOps: adopt a business perspective and explores opportunities, translates this thinking into actionable plans that fit with strategy. Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track.

Internal Stakeholder Management & Training

Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs. Stay in close alignment with respective Head Partner Business to oversee partner‑specific activities for ensuring timely and standardized delivery of goods and services. Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance. Stay accountable for planning, leading and delivering complex regional strategies across broad range of CSL products, while ensuring alignment with company / commercial strategies.

Skills & Abilities

Relevant Bachelor's degree or equivalent secondary education in e.G., business administration, natural sciences (biology, chemistry or pharmacy), law or regulatory affairs; advanced degree (Master's or PhD) preferred in e.G., business administration, natural sciences (biology, chemistry or pharmacy), law or regulatory affairs. Required fluency in Spanish and English, oral and written, to include the ability to read and write emails and communicate effectively with global colleagues. 7+ years of experience in oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry.

Preferred Certifications

(Optional but desired) certifications in quality management and (ideally) vendor management, e.G., Certified Quality Auditor (CQA), Certified Manager of Quality (CMQ) or Certified Supplier Quality Professional (CSQP).

Partner Management Experience

Proven experience in managing relationships with third‑party vendors, incl. e.G., logistics providers or service providers. Experience in managing commercial stakeholders, matching influencing style to stakeholders to maximize impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives. Ability to work in a highly matrixed organization and to establish successful cross‑functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive.

If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .

CSL is an Equal Opportunity Employer.