Hybrid Manager RPR, GLAD & LATAM

at CSL

• Job title: Manager RPR, GLAD & LATAM
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Mexico City, Mexico

About the role

• Manager overseeing regulatory partner activities in Latin America for CSL Behring. Focus on compliance, partner management, and regional strategy execution.

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 and trainings.
• 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.

Requirements

• 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.
• (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.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL