Sr Mgr RPR LatAm Business Partner

Position Purpose:

• Regulatory Partner Responsible (RPR) focuses on partner management and oversight of partner activities
• The key interactions are Local partners, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team

Reporting Relationships:

RPR Lead LATAM

Main Responsibilities and Accountabilities:

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

Strategy (execution) & (partner) management

• 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

Strategy (execution) & (partner) management

• 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

Strategy (execution) & (partner) management

• Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs

Strategy (execution) & (partner) management

• 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

Strategy (execution) & (partner) management

• 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.

(Internal) stakeholder management and trainings

• 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